The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

NCT01061385 | Completed Results DMC

• 1 other identifier: REDUCE-IDE
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• %Excess Weight Loss

  the difference between the %EWL between treatment and control groups must be clinically significant

  36 Weeks

Secondary Outcomes (1)

• Percentage of Subjects With >=25% Excess Weight Loss (EWL)

  12 months

Study Arms (2)

ReShape Intragastric Balloon

EXPERIMENTAL

Patients receiving the ReShape Intragastric Balloon

Device: ReShape Intragastric Balloon

Control Arm

OTHER

Weight loss using behavior modification (diet and exercise counseling) alone

Other: Control Arm

Interventions

ReShape Intragastric Balloon DEVICE

Placement of ReShape Medical Intragastric Balloon for twenty four weeks

ReShape Intragastric Balloon

Control Arm OTHER

Behavioral Modification (Diet and exercise counseling) alone

Control Arm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \< 12 points, and BDI affective subscale score \< 7 points.
• Subject is able to follow requirements outlined in the protocol, including complying with the visit schedule, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, electrocardiography (ECG), and/or clinical laboratory testing;
• Subject is willing to take prescribed proton pump inhibitors (PPIs);
• Subject is able to provide written informed consent;
• If female of child-bearing potential, the subject is willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study.

You may not qualify if:

• Participating in an organized weight loss program (e.g., Weight Watchers);
• Parkinson's disease;
• Chronic narcotic use;
• Clinically relevant abdominal adhesions (e.g., history of bowel obstruction);
• History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy and cholecystectomy), obstruction, and/or adhesive peritonitis;
• History or symptoms of clinically significant esophageal or GI motility disorders;
• A hormonal or genetic cause for subject's obesity;
• A history of myocardial infarction in the previous 6 months, current New York Heart Association (NYHA) Functional Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);
• History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
• History or symptoms of inflammatory bowel disease, such as Crohn's disease;
• History or symptoms of uncontrolled or unstable thyroid disease;
• Subjects with a positive breath test for Helicobacter pylori at screening;
• History or symptoms in the past 12 months of significant irritable bowel disease, peritonitis, active esophagitis, gastric or duodenal ulceration, or GI bleeding;
• History of esophageal and/or stomach cancer.
• Type I diabetes;

Sponsors & Collaborators

• ReShape Lifesciences: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Given the small sample size of this feasibility cohort, it was not expected to show significant effectiveness.

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: ReShape Medical

lfong@reshapemedical.com

949-429-6680

Study Officials

• Mary Lou Mooney

  ReShape Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 3, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 13, 2016
• Results First Posted: December 7, 2015

Record last verified: 2016-04