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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This study has been withdrawn prior to enrollment.
(This study was withdrawn to further optimize the device.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 Medical
ClinicalTrials.gov Identifier:
NCT00534339
First received: September 21, 2007
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention
Morbid Obesity
 Device: Easyband (Telemetrically adjustable gastric banding device)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Percent excess weight loss (%EWL) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 353
Study Start Date: December 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Easyband (Telemetrically adjustable gastric banding device)
    EasyBand
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Allergan Medical, Allergan
ClinicalTrials.gov Identifier: NCT00534339     History of Changes
Other Study ID Numbers: 10042
Study First Received: September 21, 2007
Last Updated: November 29, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013