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Clinical Trial Studies
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Last Updated: May 31, 2008 - 8:42:48 AM

                                                                                                                              

Gastric Banding Clinical Trial, Recruiting Patients


By Clinical Trials


Oct 6, 2007 - 4:48:30 PM


 

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: 
  • Percent excess weight

 

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

 

Allergan Medical      800-624-4261    devicetrials@allergan.com

United States, California
      USA,  California,  United States
 

Canada, Quebec
      Canada,  Quebec,  Canada
Allergan Medical   devicetrials@allergan.com 


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
 
Weight Loss Surgery (National Library of Medicine)
Laparoscopic Weight Loss Surgery  (Cleveland Clinic Foundation)
Gastric Bypass: Is This Weight-Loss Surgery for You?  (Mayo Foundation for Medical Education and Research)
ClinicalTrials.gov: Obesity, Morbid  (National Institutes of Health)
ClinicalTrials.gov: Gastric Bypass  (National Institutes of Health)
Surgical Options for Severe Obesity  (Cleveland Clinic Foundation)
ClinicalTrials.gov: Bariatric Surgery  (National Institutes of Health)
ClinicalTrials.gov: Obesity  (National Institutes of Health)
Gastrointestinal Surgery for Severe Obesity  (National Institute of Diabetes and Digestive and Kidney Diseases)
Medicare Expands National Coverage for Bariatric Surgery Procedures  (Centers for Medicare & Medicaid Services)
Eating Habits and Gastric Bypass: What to Expect After Surgery  (Cleveland Clinic Foundation)
Gastric Bypass Diet: Nutritional Needs After Weight-Loss Surgery  (Mayo Foundation for Medical Education and Research)
Dumping Syndrome  (Mayo Foundation for Medical Education and Research)
Several Factors Contribute to Complications Following Weight Loss Surgery  (American Medical Association)
 



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