Multi-Center Pre-Bariatric Weight Loss Study

GI Dynamics

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Procedure: Sham Procedure; Device: GI Sleeve Implantable weight loss device (EndoBarrier)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469391

06-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

GI Sleeve

Experimental group

Description:

medical device that mimics gastric bypass mechanism for weight-loss

Treatment:

Device: GI Sleeve Implantable weight loss device (EndoBarrier)

Sham Control

Sham Comparator group

Treatment:

Procedure: Sham Procedure