EasyBand GOAL Trial
Not Applicable
Withdrawn
- Conditions
- Morbid Obesity
- Registration Number
- NCT00534339
- Lead Sponsor
- Allergan Medical
- Brief Summary
Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Minimum 3 year history of morbid obesity with documented failure of conservative, non-surgical means of weight reduction within 1 year prior to the screening visit;
- BMI >/= 40 kg/m2, or BMI >/= 35 kg/m2 and </= 40 kg/m2 with one or more significant medical conditions related to obesity;
- Candidate for surgical weight loss intervention
Exclusion Criteria
- Previous surgical treatment of obesity;
- Patient already implanted with a device sensitive to radiofrequency emissions (implantable pacemaker, implantable defibrillator, etc);
- Physical or emotional conditions that may prohibit surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percent excess weight loss (%EWL) 5 years
- Secondary Outcome Measures
Name Time Method