Morbid Obesity
Conditions
Brief summary
Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.
Interventions
EasyBand
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent excess weight loss (%EWL) | 5 years |
Countries
Canada, United States