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EasyBand GOAL Trial

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (This study was withdrawn to further optimize the device.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
Sponsor:
Information provided by:
Allergan

Brief Summary:
Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Easyband (Telemetrically adjustable gastric banding device) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : February 2016

Intervention Details:
    Device: Easyband (Telemetrically adjustable gastric banding device)
    EasyBand


Primary Outcome Measures :
  1. Percent excess weight loss (%EWL) [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534339


Locations
United States, California
USA, California, United States
Canada, Quebec
Canada, Quebec, Canada
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Allergan Medical Allergan Medical

Responsible Party: Allergan Medical, Allergan
ClinicalTrials.gov Identifier: NCT00534339     History of Changes
Other Study ID Numbers: 10042
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: November 2010

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms