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

Primary Purpose

Obesity, Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcend II Model 8848
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Morbid Obesity, SHAPE, IGS, Implantable Gastric Stimulator

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact Medtronic for specific site information
  • Contact Medtronic for specfici site information
  • Contact Medtronic for specific site information
  • Contact Medtronic for specific site information
  • Contact Medtronic for specific site information
  • Contact Medtronic for specific site information
  • Contact Medtronic for specific site information
  • Contact Medtronic for specific site information

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent excess weight loss (% EWL) from baseline at each study visit
Change from baseline in levels of satiety and appetite at each study visit.
Percentage change in body weight and BMI from baseline at each study visit
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization
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 to loss of weight maintenance or "relapse of weight loss"
Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments

Full Information

First Posted
September 12, 2005
Last Updated
March 26, 2015
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT00200083
Brief Title
Study of Weight Loss Using Gastric Stimulation in Obese Patients
Acronym
SHAPE
Official Title
SHAPE: Screened Health Assessment & Pacer Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedtronicNeuro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity
Keywords
Obesity, Morbid Obesity, SHAPE, IGS, Implantable Gastric Stimulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Transcend II Model 8848
Intervention Description
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 Outcome Measure Information:
Title
Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Percent excess weight loss (% EWL) from baseline at each study visit
Time Frame
Baseline and each study visit
Title
Change from baseline in levels of satiety and appetite at each study visit.
Time Frame
Baseline and each study visit
Title
Percentage change in body weight and BMI from baseline at each study visit
Time Frame
Baseline and each study visit
Title
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization
Time Frame
Baseline and 12 months.
Title
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.
Title
Time to loss of weight maintenance or "relapse of weight loss"
Time Frame
Baseline and each study visit
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Obesity Study Team Obesity Study Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
Facility Name
Contact Medtronic for specific site information
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Contact Medtronic for specfici site information
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Contact Medtronic for specific site information
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
60611
Country
United States
Facility Name
Contact Medtronic for specific site information
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

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Study of Weight Loss Using Gastric Stimulation in Obese Patients

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