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Study of Weight Loss Using Gastric Stimulation in Obese Patients — SHAPE  

Obesity Clinical Trial

Official title:
SHAPE: Screened Health Assessment & Pacer Evaluation

Clinical Trial Summary

The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.

Clinical Trial Description

The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.

SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00200083
Study type Interventional
Source MedtronicNeuro
Contact
Status Completed
Phase N/A
Start date May 2004
Completion date January 2008
View Details
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