Multi-Center Pre-Bariatric Weight Loss Study

Phase 2

Completed

• Conditions: Obesity
• Interventions: Procedure: Sham Procedure; Device: GI Sleeve Implantable weight loss device (EndoBarrier)

• Registration Number: NCT00469391
• Lead Sponsor: Morphic Medical Inc.

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

Detailed Description

This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.

Study Timeline

• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Study Start: 2007-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2010-04-06
• Disposition First Submitted QC: 2010-08-05
• Disposition First Posted: 2010-08-09
• Results First Submitted: 2016-11-01
• Results First Submitted QC: 2016-11-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-29
• Results First Posted: 2016-12-30
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• BMI > 35 with a significant comorbid condition or BMI 40-60
• Candidate for Bariatric Surgery

Exclusion Criteria

• No pathologies of the GI Tract
• No anti-coagulant or non-steroidal anti-inflammatory medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control	Sham Procedure	-
GI Sleeve	GI Sleeve Implantable weight loss device (EndoBarrier)	medical device that mimics gastric bypass mechanism for weight-loss

Primary Outcome Measures

Name	Time	Method
Percent Excess Weight Loss (%EWL) at Week 12	3 months	Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)

Trial Locations

Locations (4)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Lahey Clinic Medical Center; 🇺🇸 Burlington, Massachusetts, United States