European Union (EU) Post-Market Study on Easyband®
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00948246|
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : November 26, 2012
Last Update Posted : October 13, 2014
|Condition or disease||Intervention/treatment|
|Morbid Obesity||Device: Easyband®|
|Study Type :||Observational|
|Actual Enrollment :||112 participants|
|Official Title:||EU Post-Market Study on Easyband®|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||December 2011|
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.
- Feasibility and Ease of Implantation [ Time Frame: < 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."
- % Excess Weight Loss [ Time Frame: 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 BMI [ Time Frame: 12 months ]Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months
- Change in Weight [ Time Frame: 12 months ]Change in weight (in kilograms) at baseline to 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948246
|Cheshire, United Kingdom|