The trial device is designed to help restore the body’s natural barrier between the stomach and esophagus, avoiding need for medication.
Fifteen specialized medical sites* across the U.S. – including the University of Rochester Medical Center (URMC) – and in Italy and the Netherlands are gearing up to trial a new implantable device that could bring relief to the estimated 25 million American adults who suffer from daily heartburn.
Chronic heartburn – technically titled gastroesophogeal reflux disease, or GERD – occurs when the stomach’s acidic juices backflow into the esophagus, stirring an uncomfortable burning sensation just below the breast bone. Though a muscular ring, or sphincter, usually tightens to clamp off this backsplash, in some people this natural “plumbing” is faulty: the seal is weak, or the sphincter relaxes when it shouldn’t.
“Numerous over-the-counter antacids and prescription drugs have taken aim at alleviating the symptoms, neutralizing the acids,” said Jeffrey H. Peters, MD, chair of the Department of Surgery, who will lead the trial at the URMC site. “But this device tackles the root of the problem, working to squeeze the problematic sphincter itself and restore the barrier between these two organs.”
While GERD is rarely life-threatening, its pain can derail some patients’ daily routines, and in select cases, frequent reflux can cause serious damage to the skin-like surface of the esophagus – a condition called Barrett’s esophagus, which carries a low risk for esophageal cancer.
As the incidence of GERD is on the rise, with some research pointing to possible ties to the mounting international obesity epidemic, Peters said efforts to manage the condition have become increasingly significant.
The trial device, the LINX™ Reflux Management System, is a ring of magnetic beads that can be inserted laparoscopically (through tiny incisions) in less than an hour.
Functioning like the sphincter itself, the beads not only allow food and drink to pass through on the way down, but also assist in helping the muscle constrict to control reflux.
“In a prior feasibility study, the device helped substantially lessen the incidence of reflux for most patients,” Peters said. “We’re looking forward to trialing this technology and potentially helping to pave the way for its more mainstream use.” [The device is currently being evaluated by the FDA so is currently limited to trial use under an investigational exemption.]
While 1 in 10 Americans may experience heartburn at least once a week, often that occasional discomfort can be managed through simple lifestyle changes, such as quitting smoking, avoiding eating too close to bedtime, wearing looser fitting clothing, exercising portion control, and steering clear of greasy, spicy or acidic foods.
“This trial is geared towards individuals who have made these changes and still don’t find the relief they seek,” Peters said.
The Rochester study site is seeking 10 individuals who have endured reflux symptoms for six months or more and are attempting to manage the condition with daily medication. To see if you might qualify, or to learn more, please call 585-275-URMC (8762), or visit the trial website to connect with other trial sites (see below).
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* Information & a list of sites for the trial are provided at www.refluxstudy.com. To learn about the device, and find contact info for a site near you, click on one of the location links. The locations include:
• Los Angeles, CA (not yet enrolling as of 4/10)
• University of California-San Diego Medical Center
• Mayo Clinic, Jacksonville, FL
• Minnesota Department of Clinical Research, Plymouth
• Mayo Clinic, Rochester Minnesota
• St. Louis, MO (not yet enrolling)
• Ohio State University Medical Center, Columbus
• Knox Community Hospital, Mount Vernon, OH
• Legacy Health Systems/Oregon Clinic, Portland, OR
• Pittsburgh, PA (not yet enrolling)
• Philadelphia, PA (not yet enrolling)
• University of Rochester Medical Center, Rochester, NY
• Seattle, WA (not yet enrolling)
• Gundersen Lutheran Hospital, LaCrosse, WI
• Policlinico San Donato, Milan, Italy
• Academic Medical Center, Amsterdam, Netherlands
Source: University of Rochester Medical Center news release, Apr 10, 2009