Status:
COMPLETED
Study of Weight Loss Using Gastric Stimulation in Obese Patients
Lead Sponsor:
MedtronicNeuro
Conditions:
Obesity
Morbid Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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-blin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00200083
Start Date
May 1 2004
End Date
January 1 2008
Last Update
March 27 2015
Active Locations (8)
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1
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Washington D.C., District of Columbia, United States, 20037
2
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Gainsville, Florida, United States, 32611
3
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Chicago, Illinois, United States, 60611
4
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Boston, Massachusetts, United States, 02111