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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This study has been withdrawn prior to enrollment.
(This study was withdrawn to further optimize the device.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.)
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00534339
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 ] [ Designated as safety issue: Yes ]
Percent excess weight loss (%EWL)
Complete list of historical versions of study NCT00534339 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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EasyBand GOAL Trial
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Morbid Obesity
Device: Easyband (Telemetrically adjustable gastric banding device)
EasyBand
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00534339
10042
Not Provided
Allergan Medical, Allergan
Allergan Medical
Not Provided
Study Director: Allergan Medical Allergan Medical
Allergan
November 2010

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