A clinical trial sponsored by Ethicon Endo-Surgery is now recruiting participants for a 5 year post-approval study with the REALIZE Adjustable Gastric Band. The Realize Band is a medical device used in the treatment of morbid obesity. It is one of only two gastric banding systems that have been approved for use in the United States.

The REALIZE Band was approved for use in the United States by the FDA in 2007, following the successful completion of clinical trials which began in 2003. The current study is Phase IV of the clinical trials process, also known as the Post marketing Surveillance Trial, which involves an ongoing look at safety issues after a medical device has received permission to be marketed.

The primary purpose of the study is “to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE})of gastric banding at 4 and 5 years post implant.”

Secondary outcome measures will also be evaluated in the study, including changes in excess body weight, changes in Quality of Life, and changes in Glycosylated hemoglobin and serum lipid levels, at 4 and 5 years post implant.

To be eligible for the study, individuals must meet certain criteria, including: age of 18 to 60 years; have a Body Mass Index (BMI) greater than 40 but less than 55, or between 35 and 40 with one or more co-morbid conditions; acceptable candidate for major surgery; and able to comprehend, follow and give informed consent.

Exclusion criteria includes: individuals who have undergone previous methods of weight loss surgery; women who are currently pregnant; documented history of drug and/or alcohol abuse within last 2 years; and the presence of any medical conditions which would make patient unsuitable for the procedure.

Individuals who are interested in the REALIZE Band study, including patient eligibility criteria and recruiting contacts and locations, can find out more at ClinicalTrials.gov.