Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
NCT ID: NCT01766037
Last Updated: 2020-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
171 participants
INTERVENTIONAL
2012-11-13
2019-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Lifestyle Therapy
Lifestyle Therapy only
Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Interventions
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Aspiration Therapy (AspireAssist)
Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
21 Years
65 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Cornell University
OTHER
Howard University
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
Aspire Bariatrics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Thompson, MS, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Dept VA San Diego Health Care System
San Diego, California, United States
Howard University Center for Wellness and Weight Loss Surgery
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Aspire Bariatrics, Inc. Study Sponsor Website
Other Identifiers
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P12-001V
Identifier Type: -
Identifier Source: org_study_id
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