European Union (EU) Post-Market Study on Easyband®

Allergan

Status: Completed

Conditions: Morbid Obesity

Treatments: Device: Easyband®

Study type: Observational

Funder types: Industry

Identifiers

NCT00948246

CIP10088

Details and patient eligibility

About

The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Demonstrated failure in losing weight with non-invasive therapies
• BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and < 40 kg/m2 with one or more significant medical conditions related to obesity

Exclusion criteria

• patients with BMI greater than 60 kg/m2
• patients who are not indicated for laparoscopic bariatric surgery
• patients with known allergies to implant materials such as silicone and PEEK
• patients whose abdominal structures have been damaged during preceding surgical procedures
• pregnant women
• patients under the age of 18 years
• patients treated with steroids
• patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions
• patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc

Trial design

112 participants in 1 patient group

Easyband

Description:

Subjects who had the Easyband device implanted laparoscopically.

Treatment:

Device: Easyband®