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OpenTrials
Completed

NCT Number: NCT00469391

Multi-Center Pre-Bariatric Weight Loss Study

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinic Florida, Weston, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GI Sleeve Implantable weight loss device (EndoBarrier)

Device

device for weight loss

Other names: endobarrier

Sham Procedure

Procedure

Weight loss

Other names: Sham

Primary outcomes

  1. Percent Excess Weight Loss (%EWL) at Week 12

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Morphic Medical Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 4, 2007
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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