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Multi-Center Pre-Bariatric Weight Loss Study

NCT00469391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-02-15

Study results available
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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.

Conditions

Interventions

DEVICE

GI Sleeve Implantable weight loss device (EndoBarrier)

device for weight loss

PROCEDURE

Sham Procedure

Weight loss

Sponsors & Collaborators

  • Morphic Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Tarnoff, MD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00469391 on ClinicalTrials.gov