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

March 26, 2015 updated by: MedtronicNeuro

SHAPE: Screened Health Assessment & Pacer Evaluation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Contact Medtronic for specific site information
    • Florida
      • Gainsville, Florida, United States, 32611
        • Contact Medtronic for specfici site information
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Contact Medtronic for specific site information
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Contact Medtronic for specific site information
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Contact Medtronic for specific site information
    • Missouri
      • St. Louis, Missouri, United States, 60611
        • Contact Medtronic for specific site information
    • New York
      • New York, New York, United States, 10032
        • Contact Medtronic for specific site information
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Contact Medtronic for specific site information

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent excess weight loss (% EWL) from baseline at each study visit
Time Frame: Baseline and each study visit
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
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
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.
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.
Baseline and each study visit.
Time to loss of weight maintenance or "relapse of weight loss"
Time Frame: Baseline and each study visit
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.
During the course of the study until termination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Study Chair: Obesity Study Team Obesity Study Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95-2002-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Transcend II Model 8848

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe