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

September 12, 2005
January 13, 2009
May 2004
September 2005   (final data collection date for primary outcome measure)
Percent excess weight loss (%EWL) from baseline after 12 months from randomization. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
Percent Excess Weight Loss
Complete list of historical versions of study NCT00200083 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in body weight and BMI
  • Effect on satiety and appetite
Not Provided
Not Provided
 
Study of Weight Loss Using Gastric Stimulation in Obese Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Morbid Obesity
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
January 2008
September 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200083
95-2002-015
Yes
Medtronic Inc, Clinical research specialist
MedtronicNeuro
Not Provided
Study Chair: Obesity Study Team Obesity Study Team Medtronic
MedtronicNeuro
January 2009

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