Study of Weight Loss Using Gastric Stimulation in Obese Patients - Full Text View

Sponsored by:	MedtronicNeuro
Information provided by:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00200083

Purpose

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

Condition	Intervention
Obesity Morbid Obesity	Device: Transcend II Model 8848

MedlinePlus related topics: Obesity Weight Control

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	SHAPE: Screened Health Assessment & Pacer Evaluation

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

Percent excess weight loss (%EWL) from baseline after 12 months from randomization. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent excess weight loss (% EWL) from baseline at each study visit [ Time Frame: Baseline and each study visit ] [ Designated as safety issue: No ]
Change from baseline in levels of satiety and appetite at each study visit. [ Time Frame: Baseline and each study visit ] [ Designated as safety issue: No ]
Percentage change in body weight and BMI from baseline at each study visit [ Time Frame: Baseline and each study visit ] [ Designated as safety issue: No ]
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization [ Time Frame: Baseline and 12 months. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Time to loss of weight maintenance or "relapse of weight loss" [ Time Frame: Baseline and each study visit ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: Yes ]

Enrollment:	190
Study Start Date:	May 2004
Study Completion Date:	January 2008
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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 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: Placebo Comparator 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 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.

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.

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200083

Locations

United States, District of Columbia
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Washington, District of Columbia, United States, 20037
United States, Florida
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Gainsville, Florida, United States, 32611
United States, Illinois
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Chicago, Illinois, United States, 60611
United States, Massachusetts
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Boston, Massachusetts, United States, 02111
United States, Minnesota
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Minneapolis, Minnesota, United States, 55416
United States, Missouri
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St. Louis, Missouri, United States, 60611
United States, New York
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New York, New York, United States, 10032
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

MedtronicNeuro

Investigators

Study Chair:

Obesity Study Team Obesity Study Team

Medtronic

More Information

Responsible Party:	Clinical research specialist ( Medtronic Inc )
Study ID Numbers:	95-2002-015
Study First Received:	September 12, 2005
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00200083
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:

Obesity
Morbid Obesity
SHAPE
IGS
Implantable Gastric Stimulator

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 16, 2009