Study of Weight Loss Using Gastric Stimulation in Obese Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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SHAPE: Screened Health Assessment & Pacer Evaluation

Conditions
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Obesity, Morbid Obesity

Intervention / Treatment
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* Device: Transcend II Model 8848


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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. | Device: Transcend II Model 8848<br>* All subjects will be implanted with the IGS device and then randomized to on or off for 12 months. After 12 months all subjects will be turned on through 24 month follow up.<br>|
| Placebo Comparator: B<br>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. | Device: Transcend II Model 8848<br>* All subjects will be implanted with the IGS device and then randomized to on or off for 12 months. After 12 months all subjects will be turned on through 24 month follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent excess weight loss (%EWL) from baseline after 12 months from randomization. |  | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent excess weight loss (% EWL) 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 | 
| Percentage change in body weight and BMI from baseline at each study visit |  | Baseline and each study visit | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Morbid Obesity, SHAPE, IGS, Implantable Gastric Stimulator