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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT00948246
First received: July 28, 2009
Last updated: October 6, 2014
Last verified: October 2012
  Purpose

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:

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
Easyband
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948246

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

No publications provided

Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov 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 6, 2014
Health Authority: Belgium: C.U.B. Hôpital Erasme - ULB
Netherlands: St Antonius Ziekenhuis Secretariaat LTME

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

ClinicalTrials.gov processed this record on October 30, 2014