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

Morbid Obesity Clinical Trial

Official title:

EU Post-Market Study on Easyband®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948246
• Other study ID #: CIP10088
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: October 6, 2014
• Start date: April 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: C.U.B. Hôpital Erasme - ULBNetherlands: St Antonius Ziekenhuis Secretariaat LTME
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	% 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	No
Secondary	Change in BMI	Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months	12 months	No
Secondary	Change in Weight	Change in weight (in kilograms) at baseline to 12 months	12 months	No