A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01673698
• Lead Sponsor: ReShape Lifesciences

Brief Summary

The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Disposition First Submitted: 2014-10-02
• Disposition First Submitted QC: 2014-10-02
• Disposition First Posted: 2014-10-09
• Results First Submitted: 2015-08-25
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-02
• Last Update Submitted: 2015-11-02
• Results First Posted: 2015-12-07
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24	Week 24	An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Treatment Group Responder Rate Dichotomized at 25% EWL	24 weeks	An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%.

Secondary Outcome Measures

Name	Time	Method
Weight Loss Maintenance Six Months Following Device Removal	48 weeks	Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.

Trial Locations

Locations (8)

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Hamilton Medical Center; 🇺🇸 Dalton, Georgia, United States

Marquette General Surgical Weight Loss Center; 🇺🇸 Marquette, Michigan, United States

University of Minnesota/Department of Gastrointestinal Surgery; 🇺🇸 Minneapolis, Minnesota, United States

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States

Greenville Hospital System; 🇺🇸 Simpsonville, South Carolina, United States

Midsouth Bariatrics; 🇺🇸 Memphis, Tennessee, United States

University of TX Health Science Center at Houston; 🇺🇸 Houston, Texas, United States