Back to results

Multi-Center Pre-Bariatric Weight Loss Study

Primary Purpose

Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GI Sleeve Implantable weight loss device (EndoBarrier)

Sham Procedure

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight Reduction

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Cleveland Clinic Florida
Lahey Clinic Medical Center
Dartmouth-Hitchcock Medical Center
Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

GI Sleeve

Sham Control

Arm Description

medical device that mimics gastric bypass mechanism for weight-loss

Outcomes

Primary Outcome Measures

Percent Excess Weight Loss (%EWL) at Week 12

Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)

Secondary Outcome Measures

Full Information

NCT ID

NCT00469391

First Posted

May 3, 2007

Last Updated

December 29, 2016

Sponsor

GI Dynamics

1. Study Identification

Unique Protocol Identification Number

NCT00469391

Brief Title

Multi-Center Pre-Bariatric Weight Loss Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GI Dynamics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Weight Reduction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GI Sleeve

Arm Type

Experimental

Arm Description

medical device that mimics gastric bypass mechanism for weight-loss

Arm Title

Sham Control

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

GI Sleeve Implantable weight loss device (EndoBarrier)

Other Intervention Name(s)

endobarrier

Intervention Description

device for weight loss

Intervention Type

Procedure

Intervention Name(s)

Sham Procedure

Other Intervention Name(s)

Sham

Intervention Description

Weight loss

Primary Outcome Measure Information:

Title

Percent Excess Weight Loss (%EWL) at Week 12

Description

Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Tarnoff, MD

Organizational Affiliation

Tufts Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Cleveland Clinic Florida

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Facility Name

Lahey Clinic Medical Center

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

De-identified individual patient data is on file at the Sponsor

Learn more about this trial

Multi-Center Pre-Bariatric Weight Loss Study

We'll reach out to this number within 24 hrs