EasyBand GOAL Trial
Verified by Allergan Medical September 2007
| Sponsored by: |
Allergan Medical |
| Information provided by: |
Allergan Medical |
| ClinicalTrials.gov Identifier: |
NCT00534339 |
|
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)
|
MedlinePlus
related topics:
Obesity
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further study details as provided by Allergan Medical:
Primary Outcome Measures:
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00534339
United States, California
USA, California, United States
Canada, Quebec
Canada, Quebec, Canada
Study chairs or principal investigators
Allergan Medical, Study Director, Allergan Medical
More Information
Study ID Numbers: 10042
Last Updated: September 25, 2007
Record first received: September 21, 2007
ClinicalTrials.gov Identifier:
NCT00534339
Health Authority: United States: Food and Drug Administration
