Study of Weight Loss Using Gastric Stimulation in Obese Patients

N/ACompletedNCT00200083

MedtronicNeuro190 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Obesity Morbid Obesity

Interventions

Transcend II Model 8848DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (8)

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Washington D.C., District of Columbia, United States

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Gainsville, Florida, United States

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Chicago, Illinois, United States

Outcomes

Primary Outcomes

Percent excess weight loss (%EWL) from baseline after 12 months from randomization.

Time frame: Baseline, 12 months

Secondary Outcomes

Percent excess weight loss (% EWL) from baseline at each study visit

Time frame: Baseline and each study visit

Change from baseline in levels of satiety and appetite at each study visit.

Time frame: Baseline and each study visit

Percentage change in body weight and BMI from baseline at each study visit

Time frame: Baseline and each study visit

Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization

Time frame: 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)

Time frame: Baseline and each study visit.

Time to loss of weight maintenance or "relapse of weight loss"

Time frame: Baseline and each study visit

Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments

Time frame: During the course of the study until termination.

Data from ClinicalTrials.gov

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