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

EU Post-Market Study on Easyband®

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 Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Device: Easyband®

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
• Italy
  • Peschiera, Italy
• Netherlands
  • Nieuwegein, Netherlands
• United Kingdom
  • Cheshire, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Weight loss clinic and bariatric surgeon clinics within a hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and Ease of Implantation	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."	< 1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Excess Weight Loss	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.	12 months
Change in BMI	Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months	12 months
Change in Weight	Change in weight (in kilograms) at baseline to 12 months	12 months

Collaborators and Investigators

• Sponsor: Allergan Medical

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 28, 2009
• First Submitted That Met QC Criteria: July 28, 2009
• First Posted (Estimate): July 29, 2009

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CIP10088