Study of Weight Loss Using Gastric Stimulation in Obese Patients

Obesity Clinical Trial

— SHAPE  

Official title:

SHAPE: Screened Health Assessment & Pacer Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200083
• Other study ID #: 95-2002-015
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: March 26, 2015
• Start date: May 2004
• Est. completion date: January 2008

Study information

• Verified date: March 2015
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 2008
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	Contact Medtronic for specific site information	Boston	Massachusetts
United States	Contact Medtronic for specific site information	Chicago	Illinois
United States	Contact Medtronic for specfici site information	Gainsville	Florida
United States	Contact Medtronic for specific site information	Minneapolis	Minnesota
United States	Contact Medtronic for specific site information	New York	New York
United States	Contact Medtronic for specific site information	Philadelphia	Pennsylvania
United States	Contact Medtronic for specific site information	St. Louis	Missouri
United States	Contact Medtronic for specific site information	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent excess weight loss (%EWL) from baseline after 12 months from randomization.		Baseline, 12 months	No
Secondary	Percent excess weight loss (% EWL) from baseline at each study visit		Baseline and each study visit	No
Secondary	Change from baseline in levels of satiety and appetite at each study visit.		Baseline and each study visit	No
Secondary	Percentage change in body weight and BMI from baseline at each study visit		Baseline and each study visit	No
Secondary	Proportion of subjects who attain = 20% EWL from baseline after 12 months from randomization		Baseline and 12 months.	No
Secondary	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)		Baseline and each study visit.	No
Secondary	Time to loss of weight maintenance or "relapse of weight loss"		Baseline and each study visit	No
Secondary	Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments		During the course of the study until termination.	Yes