At a glance
ClinicalIndex Comparison RecordN/ACompleted· 112 enrolled
Drug / intervention
Easyband®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EU Post-Market Study on Easyband®
In Brief
An observational study evaluating Easyband® for Morbid Obesity. Completed, enrolled 112 participants across 4 sites in 4 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity
CountriesBelgium, Italy, Netherlands, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedJul 2009
Primary CompletionOct 2011
Study CompletionDec 2011
TodayJul 2026
First PostedJul 29, 2009
Enrollment StartApr 1, 2009
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago
Interventions
Easyband®device
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.