Multi-Center Pre-Bariatric Weight Loss Study

NCT ID: NCT00469391

Last Updated: 2017-02-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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GI Sleeve

medical device that mimics gastric bypass mechanism for weight-loss

Group Type EXPERIMENTAL

GI Sleeve Implantable weight loss device (EndoBarrier)

Intervention Type DEVICE

device for weight loss

Sham Control

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type PROCEDURE

Weight loss

Interventions

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GI Sleeve Implantable weight loss device (EndoBarrier)

device for weight loss

Intervention Type DEVICE

Sham Procedure

Weight loss

Intervention Type PROCEDURE

Other Intervention Names

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endobarrier Sham

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Morphic Medical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Tarnoff, MD

Role: STUDY_DIRECTOR

Tufts Medical Center

Locations

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Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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06-3

Identifier Type: -

Identifier Source: org_study_id

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