NCT00469391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

December 30, 2016

Completed
Last Updated

February 15, 2017

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

May 3, 2007

Results QC Date

November 1, 2016

Last Update Submit

December 29, 2016

Conditions

Obesity

Keywords

Weight Reduction

Outcome Measures

Primary Outcomes (1)

  • Percent Excess Weight Loss (%EWL) at Week 12

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

    3 months

Study Arms (2)

GI Sleeve

EXPERIMENTAL

medical device that mimics gastric bypass mechanism for weight-loss

Device: GI Sleeve Implantable weight loss device (EndoBarrier)

Sham Control

SHAM COMPARATOR
Procedure: Sham Procedure

Interventions

GI Sleeve Implantable weight loss device (EndoBarrier)DEVICE

device for weight loss

Also known as: endobarrier
GI Sleeve
Sham ProcedurePROCEDURE

Weight loss

Also known as: Sham
Sham Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Clinical Affairs Manager
Organization
GI Dynamics, Inc.
pkeating@gidynamics.com
781.357.3261

Study Officials

  • Michael Tarnoff, MD

    Tufts Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 15, 2017

Results First Posted

December 30, 2016

Record last verified: 2016-12

Locations

US(4)