N/A
Completed N=30
The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects
Source: ClinicalTrials.gov NCT01061385 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Dec 2015
Primary outcomePrimary: %Excess Weight Loss — 20.2; 12.7 percent excess weight loss — p=0.2922
Summary
The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. The study device is designed to occupy space within the stomach and induce satiety. After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (with endoscopic placement of study device) or the control group (no placement of study device) on an unblinded basis. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48 week study duration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY %Excess Weight Loss |
20.2; 12.7 | 0.2922 |
| SECONDARY Percentage of Subjects With >=25% Excess Weight Loss (EWL) |
30; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects aged ≥ 20 years and ≤ 60 years;
- At screening, body mass index (BMI) ≥ 30 Kg/m^2 and ≤ 40 Kg/m^2;
- Have a history of obesity (BMI ≥ 30 kg/m^2) for at least 6 months and have failed other weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
- Subject is willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
- Subject has reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 24 weeks);
- At screening, total Beck Depression Inventory (BDI) score 81 mg/day), non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants or to reduce GI motility, and unwillingness to discontinue the use of these concomitant medications;
- Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study;
- Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia;
- Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential);
- Known allergy to silicone;
- A history of anemia
- Participation in another investigational trial within 1 month of screening or planned enrollment during the study period.
- Presence of peptic ulcerations, hiatal hernia (> 2 cm), patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus or other findings deemed exclusionary in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT01061385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.