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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan Medical

ClinicalTrials.gov Identifier:

NCT00948246

First received: July 28, 2009

Last updated: October 26, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 28, 2009
Last Updated Date	October 26, 2012
Start Date ^ICMJE	April 2009
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2012)	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."
Original Primary Outcome Measures ^ICMJE (submitted: July 28, 2009)	Performance and Effectiveness as measured by feasibility and ease of implantation, and weight loss, % excess weight loss and BMI reduction. Safety as measured by Adverse and Serious Adverse Events. [ Time Frame: 12 months with further 12 month follow-up ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00948246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2012)	% 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
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	European Union (EU) Post-Market Study on Easyband®
Official Title ^ICMJE	EU Post-Market Study on Easyband®
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Weight loss clinic and bariatric surgeon clinics within a hospital
Condition ^ICMJE	Morbid Obesity
Intervention ^ICMJE	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.
Study Group/Cohort (s)	Easyband Subjects who had the Easyband device implanted laparoscopically. Intervention: Device: Easyband®
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	112
Completion Date	December 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Italy, Netherlands, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00948246
Other Study ID Numbers ^ICMJE	CIP10088
Has Data Monitoring Committee	Not Provided
Responsible Party	Allergan Medical
Study Sponsor ^ICMJE	Allergan Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Allergan Medical
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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