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

This study has been completed.
Information provided by (Responsible Party):
Allergan Medical Identifier:
First received: July 28, 2009
Last updated: October 26, 2012
Last verified: October 2012

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 Intervention
Morbid Obesity
Device: Easyband®

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EU Post-Market Study on Easyband®

Resource links provided by NLM:

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Feasibility and Ease of Implantation [ Time Frame: < 1day ] [ Designated as safety issue: No ]
    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:
  • % Excess Weight Loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months

  • Change in Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in weight (in kilograms) at baseline to 12 months

Enrollment: 112
Study Start Date: April 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00948246

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

No publications provided

Responsible Party: Allergan Medical Identifier: NCT00948246     History of Changes
Other Study ID Numbers: CIP10088
Study First Received: July 28, 2009
Results First Received: June 27, 2012
Last Updated: October 26, 2012
Health Authority: Belgium: C.U.B. Hôpital Erasme - ULB
Netherlands: St Antonius Ziekenhuis Secretariaat LTME

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 17, 2014