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

Completed

• Conditions: Morbid Obesity
• Interventions: Device: Easyband®

• Registration Number: NCT00948246
• Lead Sponsor: Allergan Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Results First Submitted: 2012-06-27
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-26
• Results First Posted: 2012-11-26
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Easyband	Easyband®	Subjects who had the Easyband device implanted laparoscopically.

Primary Outcome Measures

Name	Time	Method
Feasibility and Ease of Implantation	< 1day	Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible."

Secondary Outcome Measures

Name	Time	Method
% Excess Weight Loss	12 months	Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.
Change in Weight	12 months	Change in weight (in kilograms) at baseline to 12 months
Change in BMI	12 months	Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months