EasyBand GOAL Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534339
Recruitment Status : Withdrawn (This study was withdrawn to further optimize the device. No patients were enrolled in the trial.)
First Posted : September 24, 2007
Last Update Posted : October 7, 2014
Information provided by:

September 21, 2007
September 24, 2007
October 7, 2014
December 2010
April 2012   (Final data collection date for primary outcome measure)
Percent excess weight loss (%EWL) [ Time Frame: 5 years ]
Percent excess weight loss (%EWL)
Complete list of historical versions of study NCT00534339 on Archive Site
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EasyBand GOAL Trial
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Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.
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Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Morbid Obesity
Device: Easyband (Telemetrically adjustable gastric banding device)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2016
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Minimum 3 year history of morbid obesity with documented failure of conservative, non-surgical means of weight reduction within 1 year prior to the screening visit;
  • BMI >/= 40 kg/m2, or BMI >/= 35 kg/m2 and </= 40 kg/m2 with one or more significant medical conditions related to obesity;
  • Candidate for surgical weight loss intervention

Exclusion Criteria:

  • Previous surgical treatment of obesity;
  • Patient already implanted with a device sensitive to radiofrequency emissions (implantable pacemaker, implantable defibrillator, etc);
  • Physical or emotional conditions that may prohibit surgery
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Allergan Medical, Allergan
Allergan Medical
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Study Director: Allergan Medical Allergan Medical
November 2010

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