Study of Weight Loss Using Gastric Stimulation in Obese Patients (SHAPE)

This study has been completed.

Sponsor:

Information provided by:

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00200083

First received: September 12, 2005

Last updated: January 13, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 13, 2009

Start Date ^ICMJE

May 2004

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Percent Excess Weight Loss

Change History

Complete list of historical versions of study NCT00200083 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Change in body weight and BMI
Effect on satiety and appetite

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Weight Loss Using Gastric Stimulation in Obese Patients

Official Title ^ICMJE

SHAPE: Screened Health Assessment & Pacer Evaluation

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Obesity
Morbid Obesity

Intervention ^ICMJE

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.

Study Arm (s)

Active Comparator: 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.

Intervention: Device: Transcend II Model 8848
Placebo Comparator: 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.

Intervention: Device: Transcend II Model 8848

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

190

Completion Date

January 2008

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00200083

Other Study ID Numbers ^ICMJE

95-2002-015

Has Data Monitoring Committee

Yes

Responsible Party

Medtronic Inc, Clinical research specialist

Study Sponsor ^ICMJE

MedtronicNeuro

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Obesity Study Team Obesity Study Team

Medtronic

Information Provided By

MedtronicNeuro

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top