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EasyBand GOAL Trial

This study has been withdrawn prior to enrollment.
(This study was withdrawn to further optimize the device. No patients were enrolled in the trial.)
Information provided by:
Allergan Identifier:
First received: September 21, 2007
Last updated: October 3, 2014
Last verified: November 2010

September 21, 2007
October 3, 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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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
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
United States,   Canada
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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