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This study has been withdrawn prior to enrollment.

( This study was withdrawn to further optimize the device.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. )

First Received on September 21, 2007. Last Updated on November 29, 2010 History of Changes

Sponsor:	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)

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:

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

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 February 09, 2012