Obesity
Conditions
Keywords
obesity, obese, weight loss
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAspiration Therapy (AspireAssist)
Use of the AspireAssist device in aspiration therapy
BEHAVIORALLifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Sponsors
Boston Medical Center
Brigham and Women's Hospital
Cornell University
Howard University
Mayo Clinic
Northwestern University
St. Mary's Medical Center
San Diego Veterans Healthcare System
University of Pennsylvania
Washington University School of Medicine
Aspire Bariatrics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Measured BMI of 35.0-55.0 kg/m2 at time of screening. 2. 21- 65 years of age (inclusive) at time of screening. 3. Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs). 4. Stable weight (\<3% change in self-reported weight) over the previous 3 months at time of screening). 5. Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit. 6. Willing and able to provide informed consent in English and comply with the protocol.
Exclusion criteria
1. Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement 2. Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease 3. History of refractory gastric ulcers 4. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination. 5. History of radiation therapy to the chest or abdomen 6. Uncontrolled hypertension (blood pressure \>160/100). 7. Diabetes treated with insulin or sulfonylurea medications 8. Any change in diabetes medication in previous 3 months 9. Hemoglobin A1C \>9.5% 10. 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 11. Coagulation disorders (platelets \< 100,000, PT \> 2 seconds above control or INR \> 1.5) 12. Anemia (Hemoglobin \<11.0 g/dL in women and \<12.5 g/dL in men) 13. Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal 14. Thyroid Stimulating Hormone (TSH) \>1.5 x upper limit of normal at screening. 15. Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values). 16. History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma) 17. Pregnant or lactating 18. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria) 19. Night Eating Syndrome (diagnosed by EDE) 20. Serum potassium \< 3.8 mEq/L 21. Chronic abdominal pain that would potentially complicate the management of the device 22. Taking a GLP-1 agonist \< 6 months. 23. 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. 24. Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids) 25. Self- reported history of substance abuse in last 3 years. 26. Malignancy in the last 5 years (except for non-melanoma skin cancer). 27. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy. 28. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Subjects Who Achieve >25% EWL | 52 weeks | The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve \> 25% EWL. |
| Mean Percent Excess Weight Loss (%EWL) | 52 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With ≥10% Total Body Weight Loss | 52 weeks | ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group |
| Mean Percent Change in Serum Lipids | 52 weeks | iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group |
| Mean Percent Change in Blood Pressure | 52 weeks | iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group |
| Mean Change in Score for IWQOL Questionnaire | 52 weeks | 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. |
| Mean Change in Hemoglobin A1C | 52 weeks | 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. |
| Procedural Success | 52 weeks | vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy |
| Change in Medications for Dyslipidemia | 52 weeks | Percent change in the number of medications taken by subjects for dyslipidemia |
| Change in Medications for Type 2 Diabetes | 52 weeks | Percent change in the number of medications taken by subjects for Type 2 Diabetes |
| Change in Number of Subjects on Hypertension Medication | 52 weeks | Percent change in the number of subjects on Hypertension medication |
| Change in Number of Subjects on Dyslipidemia Medications | 52 weeks | Percent change in the number of subjects on Dyslipidemia medications |
| Change in Number of Subjects on Diabetes Medication | 52 weeks | Percent change in the number of subjects on Diabetes medication |
| Change in Medication for Hypertension | 52 weeks | Percent change in the number of medications taken by subjects for hypertension |
| Mean Percent Total Body Weight Loss | 52 weeks | i) Mean percent absolute weight loss in AT compared to Control group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes | 52 weeks | The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed. |
Countries
United States
Participant flow
Recruitment details
First Subject Screened Oct 30, 2012; First Subject Enrolled Nov 13, 2012; Last Subject Enrolled June 13, 2014
Participants by arm
| Arm | Count |
|---|---|
| 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 | 111 |
| Lifestyle Therapy Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program | 60 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 10 |
| Overall Study | medical - unrelated | 1 | 2 |
| Overall Study | Moved from area | 5 | 0 |
| Overall Study | nausea / discomfort | 3 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 18 | 16 |
Baseline characteristics
| Characteristic | Aspiration Therapy | Lifestyle Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 60 Participants | 171 Participants |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 10 | 46.8 years STANDARD_DEVIATION 11.6 | 43.9 years STANDARD_DEVIATION 10.7 |
| Baseline Weight | 116.9 Kilograms STANDARD_DEVIATION 21.2 | 112.8 Kilograms STANDARD_DEVIATION 16.1 | 115.4 Kilograms STANDARD_DEVIATION 19.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 49 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 17 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 74 Participants | 42 Participants | 116 Participants |
| Region of Enrollment United States | 111 participants | 60 participants | 171 participants |
| Sex: Female, Male Female | 96 Participants | 53 Participants | 149 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 93 / 111 | 0 / 60 |
| serious Total, serious adverse events | 4 / 111 | 0 / 60 |
Outcome results
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.
Time frame: 52 weeks
Population: Modified Intent To Treat (mITT) population defined as all enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aspiration Therapy | Mean Percent Excess Weight Loss (%EWL) | 31.5 Percent Excess Weight Loss | Standard Deviation 26.7 |
| Lifestyle Therapy | Mean Percent Excess Weight Loss (%EWL) | 9.8 Percent Excess Weight Loss | Standard Deviation 15.5 |
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.
Time frame: 52 weeks
Population: Modified Intent To Treat (mITT) population of all enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | % of Subjects Who Achieve >25% EWL | 56.8 Percent of Subjects |
| Lifestyle Therapy | % of Subjects Who Achieve >25% EWL | 22.0 Percent of Subjects |
Secondary
Change in Medication for Hypertension
Percent change in the number of medications taken by subjects for hypertension
Time frame: 52 weeks
Population: Subjects being treated with medications for hypertension
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Change in Medication for Hypertension | -53.5 Percent Change in Medications |
| Lifestyle Therapy | Change in Medication for Hypertension | -9.4 Percent Change in Medications |
Secondary
Change in Medications for Dyslipidemia
Percent change in the number of medications taken by subjects for dyslipidemia
Time frame: 52 weeks
Population: Subjects being treated for high cholesterol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Change in Medications for Dyslipidemia | -23.1 Percent Change in Medications |
| Lifestyle Therapy | Change in Medications for Dyslipidemia | -7.7 Percent Change in Medications |
Secondary
Change in Medications for Type 2 Diabetes
Percent change in the number of medications taken by subjects for Type 2 Diabetes
Time frame: 52 weeks
Population: Subjects being treated for Type 2 Diabetes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Change in Medications for Type 2 Diabetes | -33.0 Percent Change in Medications |
| Lifestyle Therapy | Change in Medications for Type 2 Diabetes | -14.3 Percent Change in Medications |
Secondary
Change in Number of Subjects on Diabetes Medication
Percent change in the number of subjects on Diabetes medication
Time frame: 52 weeks
Population: Subjects being treated for Type II Diabetes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Change in Number of Subjects on Diabetes Medication | -33.3 % Change in Subjects on Medication |
| Lifestyle Therapy | Change in Number of Subjects on Diabetes Medication | -16.7 % Change in Subjects on Medication |
Secondary
Change in Number of Subjects on Dyslipidemia Medications
Percent change in the number of subjects on Dyslipidemia medications
Time frame: 52 weeks
Population: Subjects being treated for high cholesterol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Change in Number of Subjects on Dyslipidemia Medications | -23.1 % Change in Subjects on Medication |
| Lifestyle Therapy | Change in Number of Subjects on Dyslipidemia Medications | -8.3 % Change in Subjects on Medication |
Secondary
Change in Number of Subjects on Hypertension Medication
Percent change in the number of subjects on Hypertension medication
Time frame: 52 weeks
Population: Subjects being treated for hypertension
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Change in Number of Subjects on Hypertension Medication | -62.1 % Change in Subjects on Medication |
| Lifestyle Therapy | Change in Number of Subjects on Hypertension Medication | -10.0 % Change in Subjects on Medication |
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.
Time frame: 52 weeks
Population: Subjects with Type 2 Diabetes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aspiration Therapy | Mean Change in Hemoglobin A1C | -2.3 DCCT% change |
| Lifestyle Therapy | Mean Change in Hemoglobin A1C | -0.37 DCCT% change |
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.
Time frame: 52 weeks
Population: Subjects who completed the Questionnaire at 52 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aspiration Therapy | Mean Change in Score for IWQOL Questionnaire | 16.3 score on a scale |
| Lifestyle Therapy | Mean Change in Score for IWQOL Questionnaire | 11.7 score on a scale |
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
Time frame: 52 weeks
Population: Subjects who completed 52 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aspiration Therapy | Mean Percent Change in Blood Pressure | Systolic Pressure | -1.2 Percent Change |
| Aspiration Therapy | Mean Percent Change in Blood Pressure | Diastolic Pressure | -2.6 Percent Change |
| Lifestyle Therapy | Mean Percent Change in Blood Pressure | Systolic Pressure | -2.5 Percent Change |
| Lifestyle Therapy | Mean Percent Change in Blood Pressure | Diastolic Pressure | 0.5 Percent Change |
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
Time frame: 52 weeks
Population: Subjects who completed 52 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aspiration Therapy | Mean Percent Change in Serum Lipids | Triglycerides | -9.9 Percent Change |
| Aspiration Therapy | Mean Percent Change in Serum Lipids | High Density Lipoprotein | 8.1 Percent Change |
| Aspiration Therapy | Mean Percent Change in Serum Lipids | Low Density Lipoprotein | -4.2 Percent Change |
| Lifestyle Therapy | Mean Percent Change in Serum Lipids | High Density Lipoprotein | 1.7 Percent Change |
| Lifestyle Therapy | Mean Percent Change in Serum Lipids | Low Density Lipoprotein | -1.8 Percent Change |
| Lifestyle Therapy | Mean Percent Change in Serum Lipids | Triglycerides | 0.1 Percent Change |
Secondary
Mean Percent Total Body Weight Loss
i) Mean percent absolute weight loss in AT compared to Control group
Time frame: 52 weeks
Population: Modified Intent To Treat (mITT) population of all enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aspiration Therapy | Mean Percent Total Body Weight Loss | 12.1 Percent Total Weight Loss | Standard Deviation 9.6 |
| Lifestyle Therapy | Mean Percent Total Body Weight Loss | 3.6 Percent Total Weight Loss | Standard Deviation 6 |
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
Time frame: 52 weeks
Population: Modified Intent To Treat (mITT) population of all enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Percent of Subjects With ≥10% Total Body Weight Loss | 58.6 Percent of Subjects |
| Lifestyle Therapy | Percent of Subjects With ≥10% Total Body Weight Loss | 11.9 Percent of Subjects |
Secondary
Procedural Success
vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy
Time frame: 52 weeks
Population: All A-Tube placement attempts
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspiration Therapy | Procedural Success | 99 Percent Procedural Success |
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.
Time frame: 52 weeks
Population: Modified Intent To Treat (mITT) population of all enrolled subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aspiration Therapy | Safety Outcomes | Serious Adverse Event | 3.6 Percent of Subjects |
| Aspiration Therapy | Safety Outcomes | Diagnosed Eating Disorder | 0 Percent of Subjects |
| Lifestyle Therapy | Safety Outcomes | Serious Adverse Event | 0 Percent of Subjects |
| Lifestyle Therapy | Safety Outcomes | Diagnosed Eating Disorder | 1.7 Percent of Subjects |