Study of Weight Loss Using Gastric Stimulation in Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-01-31

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.

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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.

Conditions

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Obesity Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

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.

Group Type ACTIVE_COMPARATOR

Transcend II Model 8848

Intervention Type DEVICE

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.

B

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.

Group Type PLACEBO_COMPARATOR

Transcend II Model 8848

Intervention Type DEVICE

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.

Interventions

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Transcend II Model 8848

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No