Skip to main content
OpenTrials
Completed

NCT Number: NCT00200083

Study of Weight Loss Using Gastric Stimulation in Obese Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Medtronic for specific site information, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcend II Model 8848

Device

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.

Primary outcomes

  1. Percent excess weight loss (%EWL) from baseline after 12 months from randomization.

    Time frame: Baseline, 12 months

Secondary outcomes

  1. Percent excess weight loss (% EWL) from baseline at each study visit

    Time frame: Baseline and each study visit

  2. Change from baseline in levels of satiety and appetite at each study visit.

    Time frame: Baseline and each study visit

  3. Percentage change in body weight and BMI from baseline at each study visit

    Time frame: Baseline and each study visit

  4. Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization

    Time frame: Baseline and 12 months.

  5. 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.

  6. Time to loss of weight maintenance or "relapse of weight loss"

    Time frame: Baseline and each study visit

  7. 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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

SHAPE: Screened Health Assessment & Pacer Evaluation

Acronym: SHAPE

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.