First patient implanted in clinical trial for Gastroesophageal Reflux Disease (GERD) at Carolinas HealthCare System

Charlotte, N.C. – Carolinas HealthCare System today announced that the first patient in the Charlotte region has been implanted with a minimally-invasive device to treat reflux as part of the LESS GERD clinical trial, designed to provide long-term reflux control by restoring normal function of the esophagus through neurostimulation. The trial evaluates safety and efficacy of a minimally invasive approach for treating patients with who experience reflux symptoms despite taking high-dose proton pump inhibitor (PPI) medications.

“1 in 7 Americans experience symptoms of GERD,” said Steven Teich, MD, FACS, Carolinas HealthCare System and a principal investigator in the trial. “When you think about these numbers, it means millions of people each year need to receive treatment for their reflux,” said Teich.

GERD, a digestive disorder, occurs when stomach acid or other stomach contents flow back into the esophagus, often caused by a weak valve, or sphincter, between the esophagus and the stomach. GERD is most commonly treated with acid blocking medications, such as proton pump inhibitors (PPI).

I have had acid reflux for over 30 long years and this trial literally changed my life,” said Roger Pegram, a participant of the LESS GERD clinical trial. “Before, GERD affected how I ate, when I did, and what I did; today I’m medication free, eat what I want, when I want, and sleep on a flat bed. I can’t say enough about how this trial improved my quality of life.”

The LESS GERD trial examines the effects of the EndoStim LESS Stimulation System on GERD outcomes such as: esophageal acid exposure; GERD symptoms (heartburn and regurgitation); ability to avoid dependence on PPI medications; and the effect on overall quality of life. A minimum of 110 subjects will be implanted with the EndoStim device. The study is open to GERD patients who are between the ages of 22 and 75; have been diagnosed with GERD; have taken daily PPI medication and whose GERD symptoms are not completely resolved or have side effects from the PPI; and have had no prior surgery involving the esophagus.

About Carolinas HealthCare System

Carolinas HealthCare System (carolinashealthcare.org), one of the nation’s leading and most innovative healthcare organizations, provides a full spectrum of healthcare and wellness programs throughout North and South Carolina. Its diverse network of care locations includes academic medical centers, hospitals, freestanding emergency departments, physician practices, surgical and rehabilitation centers, home health agencies, nursing homes and behavioral health centers, as well as hospice and palliative care services. Carolinas HealthCare System works to enhance the overall health and wellbeing of its communities through high quality patient care, education and research programs, and numerous collaborative partnerships and initiatives.

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