Study of Weight Loss Using Gastric Stimulation in Obese Patients

Not Applicable

Completed

• Conditions: Obesity; Morbid Obesity
• Interventions: Device: Transcend II Model 8848

• Registration Number: NCT00200083
• Lead Sponsor: MedtronicNeuro

Brief 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.

Detailed 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 Timeline

• Study Start: 2004-05
• Primary Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2008-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• 18 to 65 years of age at time of screening
• BMI of 35 to 55 kg/m2 at time of screening
• Patients with a reported history of five years of obesity (BMI > 30 kg/m2)

Exclusion Criteria

• Patients who are excluded by the screening algorithm
• Patients scoring 29 or higher on the Binge Eating Scale Questionnaire
• Patients taking any weight loss medication or other drugs that can affect body weight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Transcend II Model 8848	All subjects enrolled will be implanted with an IGS system. The active group are those randomized to "on" and will receive active stimulation for 12 months.
B	Transcend II Model 8848	All subjects enrolled will be implanted with an IGS system. The placebo group are those randomized to "off" and will receive no stimulation for 12 months.

Primary Outcome Measures

Name	Time	Method
Percent excess weight loss (%EWL) from baseline after 12 months from randomization.	Baseline, 12 months

Secondary Outcome Measures

Name	Time	Method
Percent excess weight loss (% EWL) from baseline at each study visit	Baseline and each study visit
Percentage change in body weight and BMI from baseline at each study visit	Baseline and each study visit
Change from baseline in levels of satiety and appetite at each study visit.	Baseline and each study visit
Time to loss of weight maintenance or "relapse of weight loss"	Baseline and each study visit
Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments	During the course of the study until termination.
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization	Baseline and 12 months.
Proportion of subjects who lose ≥ 5% in body weight from baseline through Month 9, and maintain the weight loss for at least 3 months (i.e., through 12 months from randomization)	Baseline and each study visit.

Trial Locations

Locations (2)

Contact Medtronic for specific site information; 🇺🇸 Philadelphia, Pennsylvania, United States

Contact Medtronic for specfici site information; 🇺🇸 Gainsville, Florida, United States