Back to resultsEasyBand GOAL Trial
Primary Purpose
Morbid Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Easyband (Telemetrically adjustable gastric banding device)
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Percent excess weight loss (%EWL)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00534339
Brief Title
EasyBand GOAL Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn to further optimize the device. No patients were enrolled in the trial.
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan Medical
4. Oversight
5. Study Description
Brief Summary
Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Easyband (Telemetrically adjustable gastric banding device)
Intervention Description
EasyBand
Primary Outcome Measure Information:
Title
Percent excess weight loss (%EWL)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allergan Medical
Organizational Affiliation
Allergan Medical
Official's Role
Study Director
Facility Information:
City
USA
State/Province
California
Country
United States
City
Canada
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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EasyBand GOAL Trial
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