EasyBand GOAL Trial

This study is not yet open for participant recruitment.

Verified by Allergan Medical, December 2008

First Received: September 21, 2007 Last Updated: December 2, 2008 History of Changes

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

U.S. FDA Resources

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:

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

Estimated Enrollment:	300
Study Start Date:	December 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (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

Contacts

Contact: Allergan Medical

800-624-4261

devicetrials@allergan.com

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 ( Allergan Medical )
Study ID Numbers:	10042
Study First Received:	September 21, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00534339 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on May 07, 2009