HonorHealth Research Institute and EndoStim announced that the first two patients have been implanted with the EndoStim device in the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) trial.
The EndoStim system is a minimally invasive implantable device designed to provide long-term reflux control by restoring normal function to the esophagus through neurostimulation.
GERD affects nearly 65 million people in the United States1. It 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 called the lower esophageal sphincter (LES).
Frequent and troublesome symptoms can include heartburn, regurgitation, sleep disruption, vocal impairment and respiratory complications.
Most GERD is successfully treated with acid blocking medications such as proton pump inhibitors (PPI). However, nearly 30 percent of patients on PPI medication continue to suffer from symptoms.
The traditional anti-reflux surgery is laparoscopic fundoplication surgery, a procedure in which the surgeon wraps the top of the stomach around the lower esophagus to reinforce the lower esophageal sphincter. While typically effective, fundoplication can cause significant side effects.
The LESS GERD trial will evaluate the safety and efficacy of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System in patients with gastroesophageal reflux disease (GERD) who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications.
"A large number of patients still suffer from disruptive symptoms despite taking GERD medications for many years. EndoStim therapy has the potential to be an ideal option for these patients," said James Swain, M.D., Medical Director and Principal Investigator for the study at HonorHealth Research Institute.
HonorHealth Research Institute is a unique hybrid of world-class care and groundbreaking clinical trials and research. Here, leading researchers, physicians and clinical teams work together to bring newly discovered therapies and diagnostic products, as well as provide innovative care and treatments to patients.
Through the offerings of its strategic partnerships, the Institute is able to make the greatest impact on the patients' health and quality of life, by bringing tomorrow's cures that offer hope to patients today.
"The LESS GERD clinical trial is a significant undertaking to generate the first randomized, controlled, double blind evidence for a treatment for chronic GERD," said Rohan Hoare, Ph.D., President and Chief Executive Officer of EndoStim.
The LESS GERD trial will examine the effects of the EndoStim LES 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.