EasyBand GOAL Trial

Allergan

Status

Withdrawn

Conditions

Morbid Obesity

Treatments

Device: Easyband (Telemetrically adjustable gastric banding device)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00534339

10042

Details and patient eligibility

About

Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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