Status:
COMPLETED
European Union (EU) Post-Market Study on Easyband®
Lead Sponsor:
Allergan Medical
Conditions:
Morbid Obesity
Eligibility:
All Genders
18+ years
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 whe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00948246
Start Date
April 1 2009
End Date
December 1 2011
Last Update
October 13 2014
Active Locations (4)
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1
Brussels, Belgium
2
Peschiera, Italy
3
Nieuwegein, Netherlands
4
Cheshire, United Kingdom