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| Name | Class |
|---|---|
| Erbe Elektromedizin GmbH | INDUSTRY |
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This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: ESG | Active Comparator | Subjects will undergo ESG utilizing approved device alone |
|
| Treatment Group: ESG + HAPC | Experimental | Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo ESG with ERBE HAPC | Device | Utilizing two approved devices in combination to assess durability of suturing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durability | The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Total Body Weight Loss (%TBWL) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent total body weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). Total body weight loss is calculated as follows: Total Body Weight Loss (%) = [ (Starting Weight - Current Weight) / Starting Weight ] × 100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Ghanem, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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Of the 45 enrolled participants only 24 moved forward to randomization and treatment. Reasons for exclusion included non-qualifying BMI, disqualifying psychological intake findings, findings on laboratory testing or MRI, and patient refusal to complete screening activities.
Recruitment occurred at a single center, Mayo Clinic Rochester. Recruitment was primarily achieved through direct advertising leading subjects to self-refer, as well as physician referrals. 45 patients were enrolled, 24 were randomized and underwent study treatment either in the ESG arm or the ESG-HAPC arm. The last patient was enrolled in November of 2023 and the last treatment procedure was completed in January of 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group: ESG | Subjects will undergo ESG utilizing approved device alone |
| FG001 | Treatment Group: ESG + HAPC | Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group: ESG | Subjects will undergo ESG utilizing approved device alone |
| BG001 | Treatment Group: ESG + HAPC | Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Durability | The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability. | One participant in the ESG arm elected not to undergo the endoscopy at which the durability assessment is performed. | Posted | Mean | Standard Deviation | Score on a scale | 6 months |
|
From enrollment until end of follow up, up to 52 weeks post-treatment
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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: ESG | Subjects will undergo ESG utilizing approved device alone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
This is a pilot trial and therefore no formal power analysis was performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Omar Ghanem | Mayo Clinic | 507-284-2095 | ghanem.omar@mayo.edu |
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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 | Sep 24, 2024 | Jul 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized
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| Apollo ESG | Device | Using only Apollo ESG as approved per label. |
|
| 6 month |
| Percent Excess Weight Loss (%EWL) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent excess weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m^2) | 6 and 12 month |
| Blood Pressure | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Blood pressure scores analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). | 6 month |
| Percentage of Glycated Hemoglobin (% HbA1c) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis | 6 month |
| Questionnaire: Short Form (36) Health Survey [SF-36] | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 8 quality of life domains assessed, domains scores range 0-100 with a lower score indicating a worse outcome, and a higher score indicating a better outcome. | 6 month |
| Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 5 quality of life domains are scored, a higher score indicates higher quality of life relative to that domain and lower score indicates worse quality of life relative to that domain. Physical function domain (11 items scored 1-5) total scores ranging 11-55 Self-esteem domain (seven items scored 1-5) total scores ranging 7-35 Sexual life domain (four items each scored 1-5) total scores ranging 4-20 Public distress domain (five items each scored 1-5) total scores ranging 5-25 Work-related domain (four items each scored 1-5) total scores ranging 4-20 | 6 month |
| Questionnaire: Patient Health Questionnaire-9 (PHQ-9) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Score range 0-27, with a higher score indicating more severe symptoms and a lower score indicating less severe or no symptoms. | 6 month |
| Questionnaire: Eating Behavior | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Scored across three behavioral domains, higher scores in each subscale indicate a greater tendency towards that particular eating behavior. Cognitive Restraint Score range 6-28 Uncontrolled Eating Score range 9-36 Emotional Eating Score range 3-12 | 6 month |
| Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL) | Compared between treatment arms by Pearson Chi-square test. % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m^2) | 6 month |
| Binary Outcome: Incidence of Esophagitis | Compared between treatment arms by Pearson Chi-square test. | 6 month |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| BMI | Body Mass Index | Mean | Standard Deviation | kg/m² |
|
| Hypertension | Comorbidity | Count of Participants | Participants |
|
| Hyperlipidemia | Comorbidity | Count of Participants | Participants |
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| Sleep Apnea | Comorbidity | Count of Participants | Participants |
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| Mood Disorder | Count of Participants | Participants |
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| Current smoker | Count of Participants | Participants |
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| Current alcohol use | Count of Participants | Participants |
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| Type 2 diabetes mellitus | Count of Participants | Participants |
|
|
|
|
| Secondary | Percent Total Body Weight Loss (%TBWL) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent total body weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). Total body weight loss is calculated as follows: Total Body Weight Loss (%) = [ (Starting Weight - Current Weight) / Starting Weight ] × 100 | Posted | Mean | Standard Deviation | Percentage | 6 month |
|
|
|
|
| Secondary | Percent Excess Weight Loss (%EWL) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent excess weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m^2) | All 24 patients completed their weigh in at 6 months, 2 patients in the ESG arm did not weigh in at 12 months (one due to patient withdrawal, one due to patient noncompliance). | Posted | Mean | Standard Deviation | Percentage | 6 and 12 month |
|
|
|
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| Secondary | Blood Pressure | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Blood pressure scores analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). | Posted | Mean | Full Range | mm HG | 6 month |
|
|
|
|
| Secondary | Percentage of Glycated Hemoglobin (% HbA1c) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis | Posted | Mean | Standard Deviation | Percentage | 6 month |
|
|
|
|
| Secondary | Questionnaire: Short Form (36) Health Survey [SF-36] | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 8 quality of life domains assessed, domains scores range 0-100 with a lower score indicating a worse outcome, and a higher score indicating a better outcome. | Posted | Mean | Standard Deviation | Score on a scale | 6 month |
|
|
|
|
| Secondary | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 5 quality of life domains are scored, a higher score indicates higher quality of life relative to that domain and lower score indicates worse quality of life relative to that domain. Physical function domain (11 items scored 1-5) total scores ranging 11-55 Self-esteem domain (seven items scored 1-5) total scores ranging 7-35 Sexual life domain (four items each scored 1-5) total scores ranging 4-20 Public distress domain (five items each scored 1-5) total scores ranging 5-25 Work-related domain (four items each scored 1-5) total scores ranging 4-20 | Posted | Mean | Standard Deviation | Score on a scale | 6 month |
|
|
|
|
| Secondary | Questionnaire: Patient Health Questionnaire-9 (PHQ-9) | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Score range 0-27, with a higher score indicating more severe symptoms and a lower score indicating less severe or no symptoms. | Posted | Mean | Full Range | Score on a scale | 6 month |
|
|
|
|
| Secondary | Questionnaire: Eating Behavior | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Scored across three behavioral domains, higher scores in each subscale indicate a greater tendency towards that particular eating behavior. Cognitive Restraint Score range 6-28 Uncontrolled Eating Score range 9-36 Emotional Eating Score range 3-12 | Posted | Mean | Standard Deviation | Score on a scale | 6 month |
|
|
|
|
| Secondary | Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL) | Compared between treatment arms by Pearson Chi-square test. % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m^2) | Posted | Count of Participants | Participants | 6 month |
|
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|
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| Secondary | Binary Outcome: Incidence of Esophagitis | Compared between treatment arms by Pearson Chi-square test. | Posted | Count of Participants | Participants | 6 month |
|
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Treatment Group: ESG + HAPC | Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. | 0 | 12 | 0 | 12 | 10 | 12 |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| GERD | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Patchy tongue lesions | General disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 12 Months |
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| Bodily Pain |
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| General Health Perceptions |
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| Vitality (Energy and Fatigue) |
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| Social Functioning |
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| Role Limitations Due to Emotional Problems |
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| Emotional well-being |
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| Sexual life score |
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| Public distress score |
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| Work-related score |
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| Emotional eating score |
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