Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Cornell University | OTHER |
| Howard University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study is being performed to find out if a new device, AspireAssist Aspiration Therapy System, can help people with obesity to lose weight without causing too many side effects.
The Aspiration process works by "correcting" meal portions after eating by removing some of the food left in your stomach 20 minutes after your meal, which reduces the number of calories absorbed by your body. This is done through a tube placed through the abdomen into the stomach with a small valve attached at the surface of your skin. An aspiration system will attach to that valve after each major meal of the day and allow you to remove a portion of that meal.
During this study you will also be provided with Lifestyle therapy which includes behavioral therapy, diet and physical activity education. This Lifestyle therapy will also be provided to the participants who do not receive the AspireAssist so that the two groups can be compared and the benefit of aspiration for weight loss can be determined.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspiration Therapy | Experimental | Aspiration Therapy and Lifestyle Therapy |
|
| Lifestyle Therapy | Active Comparator | Lifestyle Therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspiration Therapy (AspireAssist) | Device | Use of the AspireAssist device in aspiration therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Excess Weight Loss (%EWL) | The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2. | 52 weeks |
| % of Subjects Who Achieve >25% EWL | The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Total Body Weight Loss | i) Mean percent absolute weight loss in AT compared to Control group | 52 weeks |
| Percent of Subjects With ≥10% Total Body Weight Loss | ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes | The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed. | 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
History of refractory gastric ulcers
Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.
History of radiation therapy to the chest or abdomen
Uncontrolled hypertension (blood pressure >160/100).
Diabetes treated with insulin or sulfonylurea medications
Any change in diabetes medication in previous 3 months
Hemoglobin A1C >9.5%
History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure (defined below):
Class III: patients with marked limitation of activity and who are comfortable only at rest Class IV: patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity
Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5)
Anemia (Hemoglobin <11.0 g/dL in women and <12.5 g/dL in men)
Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal
Thyroid Stimulating Hormone (TSH) >1.5 x upper limit of normal at screening.
Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values).
History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma)
Pregnant or lactating
Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)
Night Eating Syndrome (diagnosed by EDE)
Serum potassium < 3.8 mEq/L
Chronic abdominal pain that would potentially complicate the management of the device
Taking a GLP-1 agonist < 6 months.
Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 24 months.
Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
Self- reported history of substance abuse in last 3 years.
Malignancy in the last 5 years (except for non-melanoma skin cancer).
Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
At high risk of having a medical complication from the endoscopic procedure or Aspiration Therapy weight loss program for any reason, including poor general health or severe organ dysfunction, such as cirrhosis or renal dysfunction (GFR <60 mL/min/1.73 m2 at screening, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Thompson, MS, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept VA San Diego Health Care System | San Diego | California | 92161 | United States | ||
| Howard University Center for Wellness and Weight Loss Surgery |
Not provided
| Label | URL |
|---|---|
| Aspire Bariatrics, Inc. Study Sponsor Website | View source |
Not provided
No individual participant data will be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
First Subject Screened Oct 30, 2012; First Subject Enrolled Nov 13, 2012; Last Subject Enrolled June 13, 2014
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aspiration Therapy | Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program |
| FG001 | Lifestyle Therapy | Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aspiration Therapy | Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program |
| BG001 | Lifestyle Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Mean Percent Excess Weight Loss (%EWL) | The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2. | Modified Intent To Treat (mITT) population defined as all enrolled subjects | Posted | Mean | Standard Deviation | Percent Excess Weight Loss | 52 weeks |
|
52 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspiration Therapy | Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Surgical and medical procedures | Non-systematic Assessment | Peritonitis (mild pneumo-peritoneum without abscess) post endoscopic A-Tube placement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulation Tissue | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Granulation tissue at the stoma site is a normal healing process but can cause discomfort if not treated. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Regulatory & Quality | Aspire Bariatrics, Inc. | 484-200-1031 | monica.ferrante@aspirebariatrics.com |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| OTHER |
| Mayo Clinic | OTHER |
| Northwestern University | OTHER |
| St. Mary's Medical Center | OTHER |
| San Diego Veterans Healthcare System | FED |
| University of Pennsylvania | OTHER |
| Washington University School of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lifestyle Therapy | Behavioral | Lifestyle therapy is a behavioral, diet and physical activity education program |
|
|
| 52 weeks |
| Mean Percent Change in Serum Lipids | iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group | 52 weeks |
| Mean Percent Change in Blood Pressure | iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group | 52 weeks |
| Mean Change in Score for IWQOL Questionnaire | v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire total score Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points. | 52 weeks |
| Mean Change in Hemoglobin A1C | vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint. | 52 weeks |
| Procedural Success | vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy | 52 weeks |
| Change in Medication for Hypertension | Percent change in the number of medications taken by subjects for hypertension | 52 weeks |
| Change in Medications for Dyslipidemia | Percent change in the number of medications taken by subjects for dyslipidemia | 52 weeks |
| Change in Medications for Type 2 Diabetes | Percent change in the number of medications taken by subjects for Type 2 Diabetes | 52 weeks |
| Change in Number of Subjects on Hypertension Medication | Percent change in the number of subjects on Hypertension medication | 52 weeks |
| Change in Number of Subjects on Dyslipidemia Medications | Percent change in the number of subjects on Dyslipidemia medications | 52 weeks |
| Change in Number of Subjects on Diabetes Medication | Percent change in the number of subjects on Diabetes medication | 52 weeks |
| Washington D.C. |
| District of Columbia |
| 20060 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| St. Mary Medical Center | Langhorne | Pennsylvania | 19047 | United States |
| University of Pennsylvania Center for Weight and Eating Disorders | Philadelphia | Pennsylvania | 19146 | United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Moved from area |
|
| medical - unrelated |
|
| nausea / discomfort |
|
Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Weight | Mean | Standard Deviation | Kilograms |
|
| OG001 | Lifestyle Therapy | Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program |
|
|
| Primary | % of Subjects Who Achieve >25% EWL | The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL. | Modified Intent To Treat (mITT) population of all enrolled subjects | Posted | Number | 95% Confidence Interval | Percent of Subjects | 52 weeks |
|
|
|
| Secondary | Mean Percent Total Body Weight Loss | i) Mean percent absolute weight loss in AT compared to Control group | Modified Intent To Treat (mITT) population of all enrolled subjects | Posted | Mean | Standard Deviation | Percent Total Weight Loss | 52 weeks |
|
|
|
| Secondary | Percent of Subjects With ≥10% Total Body Weight Loss | ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group | Modified Intent To Treat (mITT) population of all enrolled subjects | Posted | Number | 95% Confidence Interval | Percent of Subjects | 52 weeks |
|
|
|
| Secondary | Mean Percent Change in Serum Lipids | iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group | Subjects who completed 52 weeks | Posted | Mean | 95% Confidence Interval | Percent Change | 52 weeks |
|
|
|
| Secondary | Mean Percent Change in Blood Pressure | iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group | Subjects who completed 52 weeks | Posted | Mean | 95% Confidence Interval | Percent Change | 52 weeks |
|
|
|
| Secondary | Mean Change in Score for IWQOL Questionnaire | v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire total score Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points. | Subjects who completed the Questionnaire at 52 weeks | Posted | Mean | 95% Confidence Interval | score on a scale | 52 weeks |
|
|
|
| Secondary | Mean Change in Hemoglobin A1C | vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint. | Subjects with Type 2 Diabetes | Posted | Mean | 95% Confidence Interval | DCCT% change | 52 weeks |
|
|
|
| Secondary | Procedural Success | vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy | All A-Tube placement attempts | Posted | Number | Percent Procedural Success | 52 weeks |
|
|
|
| Secondary | Change in Medication for Hypertension | Percent change in the number of medications taken by subjects for hypertension | Subjects being treated with medications for hypertension | Posted | Number | Percent Change in Medications | 52 weeks |
|
|
|
| Secondary | Change in Medications for Dyslipidemia | Percent change in the number of medications taken by subjects for dyslipidemia | Subjects being treated for high cholesterol | Posted | Number | Percent Change in Medications | 52 weeks |
|
|
|
| Secondary | Change in Medications for Type 2 Diabetes | Percent change in the number of medications taken by subjects for Type 2 Diabetes | Subjects being treated for Type 2 Diabetes | Posted | Number | Percent Change in Medications | 52 weeks |
|
|
|
| Secondary | Change in Number of Subjects on Hypertension Medication | Percent change in the number of subjects on Hypertension medication | Subjects being treated for hypertension | Posted | Number | % Change in Subjects on Medication | 52 weeks |
|
|
|
| Secondary | Change in Number of Subjects on Dyslipidemia Medications | Percent change in the number of subjects on Dyslipidemia medications | Subjects being treated for high cholesterol | Posted | Number | % Change in Subjects on Medication | 52 weeks |
|
|
|
| Secondary | Change in Number of Subjects on Diabetes Medication | Percent change in the number of subjects on Diabetes medication | Subjects being treated for Type II Diabetes | Posted | Number | % Change in Subjects on Medication | 52 weeks |
|
|
|
| Other Pre-specified | Safety Outcomes | The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed. | Modified Intent To Treat (mITT) population of all enrolled subjects | Posted | Number | Percent of Subjects | 52 weeks |
|
|
|
| 4 |
| 111 |
| 93 |
| 111 |
| EG001 | Lifestyle Therapy | Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program | 0 | 60 | 0 | 60 |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment | Abdominal pain post endoscopic A-Tube placement procedure |
|
| Prepyloric Ulceration | Gastrointestinal disorders | Non-systematic Assessment | Non-bleeding pre-pyloric ulceration |
|
| A-Tube Replacement | Surgical and medical procedures | Non-systematic Assessment | A-Tube replaced, Site documented as SAE because endoscopy was performed to replace the tube. |
|
|
| Abdominal Pain (post procedure) | Gastrointestinal disorders | Non-systematic Assessment | Abdominal pain occurring within 4 weeks of the A-Tube endoscopic placement |
|
| Peristomal Discharge | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Peristomal bleeding, discharge, inflammation, irritation |
|
| Nausea / Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Nausea and vomiting generally the result of sedation and post procedure pain medication |
|
| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment | Intermittent abdominal discomfort |
|
| Peristomal Infection | Infections and infestations | Non-systematic Assessment | Peristomal bacterial infection / possible infection |
|
| Abdominal Pain (after 4 weeks) | Gastrointestinal disorders | Non-systematic Assessment | Abdominal pain onset more than 4 weeks after A-Tube placement |
|
| Change in Bowel Habits | Gastrointestinal disorders | Non-systematic Assessment | Dyspepsia, Constipation, Diarrhea |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Triglycerides |
|