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| Name | Class |
|---|---|
| University of Texas | OTHER |
| Johns Hopkins University | OTHER |
| Brigham and Women's Hospital | OTHER |
| Endeavor Health |
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Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction.
Up to 200 participants at 9 locations in the United States will participate in this study.
The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Lifestyle Modification | Active Comparator | Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. |
|
| Treatment Group: Overstitch ESG Procedure | Experimental | Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet.ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved >25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year |
|
| Crossover Group: Lifestyle Intervention to ESG Procedure | Experimental | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overstitch Endoscopic Suture System | Device | Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Excess Weight Loss (EWL) | Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥25% EWL | Total number of participants with ≥25% excess weight loss at 12 months from randomization | 12 months |
| Number of Participants Off Or With Reduction in Antihypertensive Medications |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Barham K Abu Dayyeh | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Orlando | Florida | 32806 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36241388 | Derived | Vargas EJ, Rizk M, Gomez-Villa J, Edwards PK, Jaruvongvanich V, Storm AC, Acosta A, Lake D, Fidler J, Bharucha AE, Camilleri M, Abu Dayyeh BK. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut. 2023 Jun;72(6):1073-1080. doi: 10.1136/gutjnl-2022-327816. Epub 2022 Oct 14. | |
| 35908555 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group: Lifestyle Modification | Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Level 1: Lifestyle Modification vs ESG |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2020 |
Not provided
Not provided
| OTHER |
| University of Chicago | OTHER |
| Orlando Health, Inc. | OTHER |
| Cornell University | OTHER |
| Avera McKennan Hospital & University Health Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lifestyle Intervention | Behavioral | Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
Total number participants off or with reduction in antihypertensive medications
| 12 months |
| Change in Blood Pressure | Change in blood pressure measured in units of millimeters of mercury (mmHg) | Baseline, 12 months |
| Change in Blood Pressure for ESG Intervention From Baseline to 24 Months | Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg) | Baseline, 24 months |
| Number of Participants Off or With Reduction in Diabetes Medications | Total number of participants off or with reduction in diabetes medications | 12 months |
| Change in HgbA1c | Change in HgbA1c levels | Baseline, 12 months |
| Change in HgbA1c for ESG Intervention From Baseline to 24 Months | Change in HgbA1c levels for participants that received the ESG intervention | Baseline, 24 months |
| Percentage of Total Body Weight Loss (TBWL) | Percentage of total body weight loss in participants | 12 months |
| Number of Participants to Achieve ≥5% TBWL | Total number of participants to achieve ≥5% total body weight loss | 12 months |
| Number of Participants to Achieve ≥10% TBWL | Total number of participants to achieve ≥10% total body weight loss | 12 months |
| Esophagitis at Repeat Endoscopy | Total number of participants to have esophagitis at repeat endoscopy | 12 months |
| Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome). | Baseline, 12 months |
| Changes in Health Status Survey Scores | Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome) | Baseline, 12 months |
| Number of Participants With Major Depression or Severe Major Depression at Baseline | Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score < 10; major depression, 10 ≤ score < 20; severe major depression, x ≥ 20 | Baseline |
| Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score < 10; major depression, 10 ≤ score < 20; severe major depression, x ≥ 20 | 12 months |
| Change in Eating Behaviors | Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions) | Baseline, 12 months |
| Chicago |
| Illinois |
| 60637 |
| United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Cornell University | New York | New York | 10065 | United States |
| Avera McKennan Hospital & University Health Center | Sioux Falls | South Dakota | 57105 | United States |
| University of Texas | Houston | Texas | 77401 | United States |
| Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28. |
| FG001 | Treatment Group: Overstitch ESG Procedure | Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved >25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| FG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Level 2: Crossover Lifestyle to ESG |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group: Lifestyle Modification | Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| BG001 | Treatment Group: Overstitch ESG Procedure | Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved >25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| BG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data collected from each study are being reported separately to avoid multi-counted participants. | Median | Inter-Quartile Range | years |
| |||||||||
| Sex: Female, Male | Data collected from each study are being reported separately to avoid multi-counted participants. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Data collected from each study are being reported separately to avoid multi-counted participants. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Level 1: Lifestyle Modification vs ESG | Data collected from each year are being reported separately to avoid multi-counted participants. | Number | participants |
| |||||||||
| Region of Enrollment | Level 2: Crossover Lifestyle to ESG | Data collected from each year are being reported separately to avoid multi-counted participants. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Excess Weight Loss (EWL) | Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²) | Posted | Mean | Standard Deviation | percentage of EWL | 12 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With ≥25% EWL | Total number of participants with ≥25% excess weight loss at 12 months from randomization | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants Off Or With Reduction in Antihypertensive Medications | Total number participants off or with reduction in antihypertensive medications | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Change in Blood Pressure | Change in blood pressure measured in units of millimeters of mercury (mmHg) | Posted | Mean | Standard Deviation | mmHg | Baseline, 12 months |
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| Secondary | Change in Blood Pressure for ESG Intervention From Baseline to 24 Months | Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg) | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 months |
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| Secondary | Number of Participants Off or With Reduction in Diabetes Medications | Total number of participants off or with reduction in diabetes medications | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Change in HgbA1c | Change in HgbA1c levels | Posted | Mean | Standard Deviation | Percent of Glycosylated Hemoglobin | Baseline, 12 months |
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| Secondary | Change in HgbA1c for ESG Intervention From Baseline to 24 Months | Change in HgbA1c levels for participants that received the ESG intervention | Posted | Mean | Standard Deviation | Percent of Glycosylated Hemoglobin | Baseline, 24 months |
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| Secondary | Percentage of Total Body Weight Loss (TBWL) | Percentage of total body weight loss in participants | Posted | Mean | Standard Deviation | percentage of TBWL | 12 months |
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| Secondary | Number of Participants to Achieve ≥5% TBWL | Total number of participants to achieve ≥5% total body weight loss | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants to Achieve ≥10% TBWL | Total number of participants to achieve ≥10% total body weight loss | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Esophagitis at Repeat Endoscopy | Total number of participants to have esophagitis at repeat endoscopy | Those ESG patients who have achieved >25% EWL at the end of Level 1 will not undergo a repeat endoscopy and will continue to follow-up with a lifestyle intervention in Level 2. Those ESG patients who have not achieved >25% EWL at the end of Level 1 will undergo a repeat upper endoscopy at 52 | Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome). | Not all participants provided answers to all the domains of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Health Status Survey Scores | Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome) | Not all participants provided answers to all the domains of the SF-36 Health Status Survey questionnaire | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score < 10; major depression, 10 ≤ score < 20; severe major depression, x ≥ 20 | Posted | Count of Participants | Participants | Baseline |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score < 10; major depression, 10 ≤ score < 20; severe major depression, x ≥ 20 | Posted | Count of Participants | Participants | 12 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Eating Behaviors | Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions) | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group: Lifestyle Modification | Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | 0 | 110 | 1 | 110 | 46 | 110 |
| EG001 | Treatment Group: Overstitch ESG Procedure | Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved >25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | 0 | 77 | 12 | 77 | 77 | 77 |
| EG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | 0 | 73 | 4 | 73 | 64 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abscess intra abdominal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bloody Stool | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bowel impaction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Broken Hip | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| ED Visit-Sore Throat | General disorders | Systematic Assessment |
| ||
| ER Visit-Coffee ground emesis | General disorders | Systematic Assessment |
| ||
| ER Visit-Dehydration | General disorders | Systematic Assessment |
| ||
| Esophageal mucosal tear due to device malfunction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gangrenous cholecystitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache/migraine | General disorders | Systematic Assessment |
| ||
| Hospitalization-Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Hospitalization-Mental Health | Psychiatric disorders | Systematic Assessment |
| ||
| Hospitalization-Obstruction Intestinal (HCC) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
| ||
| Nausea and vomiting | General disorders | Systematic Assessment |
| ||
| Pleural effusion | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Post ESG Hospital Stay | General disorders | Systematic Assessment | Hospital stay past allotted 23 hours due to nausea |
| |
| Readminission | General disorders | Systematic Assessment | Readmission post procedure due to nausea/vomiting |
| |
| Vomiting | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain/Epigastric Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Spasm | Gastrointestinal disorders | Systematic Assessment |
| ||
| Allergic Reaction | Immune system disorders | Systematic Assessment |
| ||
| Anemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Back and Pelvic Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral Calf Discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral Frozen Shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Biliary Dyskinesia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bladder Spasms | Renal and urinary disorders | Systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bloody Stool | Gastrointestinal disorders | Systematic Assessment |
| ||
| Blurred Vision | Eye disorders | Systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Burning | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Burping | General disorders | Systematic Assessment |
| ||
| Calculus of Gallbladder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Chest Tightness | Cardiac disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Clinically abnormal lab findings | General disorders | Systematic Assessment |
| ||
| Cold Sore | Infections and infestations | Systematic Assessment |
| ||
| Common Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Concentrated Urine | Renal and urinary disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough, Sore Throat, Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Dark Stools | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dehydration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea, Nausea, Chills, Weakness, Muscle Aches | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Ear Infection | Infections and infestations | Systematic Assessment |
| ||
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Edema | Gastrointestinal disorders | Systematic Assessment |
| ||
| Epigastric Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Eructation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Eye Hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Eye Laceration | Eye disorders | Systematic Assessment |
| ||
| Fatigue/Lethargy | General disorders | Systematic Assessment |
| ||
| Fever | Infections and infestations | Systematic Assessment |
| ||
| Fibromyalgia | Nervous system disorders | Systematic Assessment |
| ||
| Finger Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Finger Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Flu | Infections and infestations | Systematic Assessment |
| ||
| Foot Infection | Infections and infestations | Systematic Assessment |
| ||
| Foot Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Foot Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Frozen Shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gagging on Uvula | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gas Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gel tear in eye | Eye disorders | Systematic Assessment |
| ||
| Groin Pull | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hair Loss | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Halitosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hand and Leg Tremors | Nervous system disorders | Systematic Assessment |
| ||
| Headache/Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heartburn/Reflux | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heart Murmer | Cardiac disorders | Systematic Assessment |
| ||
| Hiccups | Gastrointestinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Intraoperative Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Irregular Menstrual Bleeding | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Joint and Muscle Tenderness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Knee Replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| Left Lower Quadrant Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Left Upper Quadrant Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Loss of Taste/Smell | General disorders | Systematic Assessment |
| ||
| Lower Extremity Redness | Skin and subcutaneous tissue disorders | Systematic Assessment | possibly due to bug bite |
| |
| Lumpectomy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lyme Disease | Infections and infestations | Systematic Assessment |
| ||
| Lymphedema | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Mediastinal Lymphadenopathy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Memory Loss | Nervous system disorders | Systematic Assessment |
| ||
| Metallic Taste in Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea & Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea and Stomach Ache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Night Sweats | General disorders | Systematic Assessment |
| ||
| Oral Thrush | Gastrointestinal disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Parotid Salivary Gland Obstruction | Endocrine disorders | Systematic Assessment |
| ||
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pinched Nerve in Neck | Nervous system disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pus in Old Wound Site (abdominal) | Infections and infestations | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rectal Bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Recurrent Abdominal Abscess | Infections and infestations | Systematic Assessment |
| ||
| RLQ Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Right Finger Redness | Skin and subcutaneous tissue disorders | Systematic Assessment | Possible bug bite |
| |
| Runny Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RUQ Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Shakiness | Nervous system disorders | Systematic Assessment |
| ||
| Shin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Sore Throat | Infections and infestations | Systematic Assessment |
| ||
| Sprained Ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Stiffness, Bruising, Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Strep Throat | Infections and infestations | Systematic Assessment |
| ||
| Syncope | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Tailor's Bunion of Right Foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Tingling Down Arms and Shoulders | Nervous system disorders | Systematic Assessment |
| ||
| Tinnitis | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Toe Fungus | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | General disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Umbilical Discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| UTI | Renal and urinary disorders | Systematic Assessment |
| ||
| Urine Frequency/Urgency | Renal and urinary disorders | Systematic Assessment |
| ||
| Virus | Infections and infestations | Systematic Assessment |
| ||
| Vaginal Bleeding (2nd time) | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
| ||
| White Tongue | Infections and infestations | Systematic Assessment |
| ||
| Xyphoid Process Pain | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barham Abu Dayyeh | Mayo Clinic | 507-266-4347 | AbuDayyeh.Barham@mayo.edu |
| May 6, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
|
| Level 2: Crossover Lifestyle to ESG |
|
|
|
| Level 2: Crossover Lifestyle to ESG |
|
|
|
| Level 2: Crossover Lifestyle to ESG |
|
|
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG001 |
| Treatment Group: Overstitch ESG Procedure |
Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved >25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| OG002 | Crossover Group: Lifestyle Intervention to ESG Procedure | Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. |
|
|
| Asian |
|
| Hispanic/Latino |
|
| Other |
|
| Deferred |
|