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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: SHAPE: Screened Health Assessment & Pacer Evaluation

Resource links provided by NLM:


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
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, District of Columbia
Contact Medtronic for specific site information
Washington, District of Columbia, United States, 20037
United States, Florida
Contact Medtronic for specfici site information
Gainsville, Florida, United States, 32611
United States, Illinois
Contact Medtronic for specific site information
Chicago, Illinois, United States, 60611
United States, Massachusetts
Contact Medtronic for specific site information
Boston, Massachusetts, United States, 02111
United States, Minnesota
Contact Medtronic for specific site information
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Contact Medtronic for specific site information
St. Louis, Missouri, United States, 60611
United States, New York
Contact Medtronic for specific site information
New York, New York, United States, 10032
United States, Pennsylvania
Contact Medtronic for specific site information
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Chair: Obesity Study Team Obesity Study Team Medtronic
  More Information

No publications provided

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

Keywords provided by MedtronicNeuro:
Obesity
Morbid Obesity
SHAPE
IGS
Implantable Gastric Stimulator

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014