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First patients receive EndoStim implants in clinical trial for GERD
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The first patients enrolled in the LESS GERD trial have been implanted with the EndoStim device, a minimally invasive implant that uses neurostimulation to normalize esophageal function and provide long-term reflux control, the manufacturer announced.
Researchers performed these first implants at Dignity Health St. Joseph’s Hospital and Medical Center in Phoenix, Arizona, and at the Stanford University School of Medicine.
Sixteen centers and at least 110 GERD patients aged 22 to 75 years who have persistent symptoms despite high-dose PPIs will participate in the trial to assess the device’s safety and efficacy. Outcomes of interest include esophageal acid exposure, GERD symptoms like heartburn and regurgitation, patients’ ability to stop taking PPIs regularly, and quality of life.
“We are excited to start the LESS GERD clinical trial to generate evidence for a novel new treatment for chronic GERD, an undertreated disease that is disrupting the lives of millions of patients worldwide,” Rohan Hoare, PhD, president and CEO of EndoStim, said in a press release. “Unlike many common treatment options that work to alleviate GERD symptoms, EndoStim targets the underlying pathophysiology of GERD with the potential to restore normal function to the lower esophageal sphincter.”
Healio Gastroenterology previously reported on the results of a 1-year multicenter trial of the EndoStim device, which were presented at DDW 2016.
Disclosures: Hoare is employed by EndoStim.