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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This study has been withdrawn prior to enrollment.
(This study was withdrawn to further optimize the device.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
  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:


Further study details as provided by Allergan:

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

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014