Multi-Center Pre-Bariatric Weight Loss Study

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: GI Sleeve Implantable weight loss device (EndoBarrier); Procedure: Sham Procedure

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28232
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Control	Procedure: Sham Procedure; Weight loss; Other Names: Sham
Experimental: GI Sleeve; medical device that mimics gastric bypass mechanism for weight-loss	Device: GI Sleeve Implantable weight loss device (EndoBarrier); device for weight loss; Other Names: endobarrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Excess Weight Loss (%EWL) at Week 12	Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)	3 months

Collaborators and Investigators

• Sponsor: GI Dynamics
• Investigators: Study Director: Michael Tarnoff, MD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 4, 2007

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Weight Reduction
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 06-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: De-identified individual patient data is on file at the Sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No