European Union (EU) Post-Market Study on Easyband®
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||EU Post-Market Study on Easyband®|
- Feasibility and Ease of Implantation [ Time Frame: < 1day ] [ Designated as safety issue: No ]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."
- % Excess Weight Loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months
- Change in Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in weight (in kilograms) at baseline to 12 months
|Study Start Date:||April 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Subjects who had the Easyband device implanted laparoscopically.
The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna.