HOUSTON - (Nov. 14, 2011) - Physicians at The University of Texas Health Science Center at Houston (UTHealth) Medical School are recruiting adults with chronic reflux for a clinical trial on an innovative procedure designed to provide long-lasting relief.
Reflux is the abnormal regurgitation of stomach and intestinal contents into the esophagus, which is the muscular tube connecting the mouth and stomach.
An estimated 60 million Americans experience acid reflux each month and it can create a burning sensation likened to battery acid. It can occur when a valve designed to contain stomach acid does not work properly. The acid can back up into the esophagus.
“We are one of a select group of sites in the United States chosen to participate in the study,” said Erik Wilson, M.D., a study principal investigator at the Houston site and director of Minimally Invasive Surgeons of Texas at UTHealth. “The fundamentals of the procedure have been studied in animals and humans. We’re gathering additional data on outcomes.”
For the vast majority, acid reflux is an inconvenience and can be treated with medication. However for people who experience reflux on a regular basis, it can become a significant health risk, developing into a severe chronic disorder known as Gastroesophageal Reflux Disease (GERD).
If not managed, acid reflux or GERD can lead to inflammation of the esophagus, esophageal bleeding and ulcers and Barrett’s esophagus, a serious condition tied to cancer.
Nationwide, 120 people are being recruited for a multi-center, randomized trial for the treatment of GERD. Two out of three participants will receive the incisionless procedure and a placebo medication. The remainder will get a control procedure and a medication called omeprazole, said Wilson, who is on the medical staff of Memorial Hermann-Texas Medical Center.
Afterward, researchers will compare data to better understand the relative merits, safety and effectiveness of the procedure known as an advanced Transoral Incisionless Fundoplication (TIF), which is approved by the Food and Drug Administration.
Locally, Wilson hopes to recruit at least 15 people. Eligible participants will receive multiple follow-up checkups over the course of 12 months. Once the study is over, the procedure will be offered to those who originally received the control procedure. There is no charge for the procedure.
Wilson’s team is looking for people 18 to 80 years of age who have chronic symptoms and have been taking a medication to control symptoms.
With the aid of a tiny television camera and slender instruments inserted through the patient’s mouth, doctors can fortify the valve designed to keep stomach acid and bile from reaching the esophagus. The procedure is done while the patient is under a general anesthetic.
Other institutions involved in the trial include Oregon Health & Science University, Northwestern University, The Oregon Clinic, University of South Florida, Reston Surgical Associates and Ohio State University.
People interested in enrolling in the study should call Anna Cecilia Tenorio at 713-486-1350 to determine eligibility. Participants may be asked to complete screening tests that may be covered by insurance.
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