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. Identifier: NCT00948246
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : November 26, 2012
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
Allergan ( Allergan Medical )

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 where the device is a CE marked approved product.

Condition or disease Intervention/treatment
Morbid Obesity Device: Easyband®

Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Subjects who had the Easyband device implanted laparoscopically.
Device: Easyband®
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.

Primary Outcome Measures :
  1. 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."

Secondary Outcome Measures :
  1. % 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.

  2. Change in BMI [ Time Frame: 12 months ]
    Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months

  3. Change in Weight [ Time Frame: 12 months ]
    Change in weight (in kilograms) at baseline to 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Weight loss clinic and bariatric surgeon clinics within a hospital

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00948246

Brussels, Belgium
Peschiera, Italy
Nieuwegein, Netherlands
United Kingdom
Cheshire, United Kingdom
Sponsors and Collaborators
Allergan Medical

Responsible Party: Allergan Medical Identifier: NCT00948246     History of Changes
Other Study ID Numbers: CIP10088
First Posted: July 29, 2009    Key Record Dates
Results First Posted: November 26, 2012
Last Update Posted: October 13, 2014
Last Verified: October 2012

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms