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

Study Identifier
CIP10088
CT.gov Identifier
NCT00948246
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Obesity or Weight Loss
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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

    Protocol 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 Locations

    Location
    Status
    Location
    Brussels, Belgium
    Status
    Not applicable
    Location
    Peschiera, Italy
    Status
    Not applicable
    Location
    Nieuwegein, Netherlands
    Status
    Not applicable
    Location
    Cheshire, United Kingdom
    Status
    Not applicable