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

July 28, 2009
October 6, 2014
April 2009
October 2011   (final data collection date for primary outcome measure)
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."
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 ]
Complete list of historical versions of study NCT00948246 on ClinicalTrials.gov Archive Site
  • % 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
Not Provided
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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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Weight loss clinic and bariatric surgeon clinics within a hospital

Morbid Obesity
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.
Easyband
Subjects who had the Easyband device implanted laparoscopically.
Intervention: Device: Easyband®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Netherlands,   United Kingdom
 
NCT00948246
CIP10088
Not Provided
Allergan ( Allergan Medical )
Allergan Medical
Not Provided
Not Provided
Allergan
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP