NCT00469391

Multi-Center Pre-Bariatric Weight Loss Study

A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Morphic Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	GI Sleeve Implantable weight loss device (EndoBarrier)	device for weight loss
PROCEDURE	Sham Procedure	Weight loss

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-05-04
• Last updated: 2017-02-15
• Results posted: 2016-12-30

Locations

4 sites across 1 country: United States