LOS ANGELES and ST. LOUIS, Nov. 3, 2016 /PRNewswire/ -- EndoStim, Inc., announced that the first patient has been implanted with the EndoStim device in the LESS GERD trial, at the University of Southern California. The results from the trial will support EndoStim's premarket approval application to the U.S. Food and Drug Administration (FDA).
The LESS GERD trial will include a minimum of 110 subjects implanted with the EndoStim device at up to 30 sites in the United States and Europe. The trial is a multicenter, randomized, double-blind, sham-controlled pivotal trial designed to evaluate the safety and efficacy of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System in patients with gastro-esophageal reflux disease (GERD) who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications.
The lead investigators of the LESS GERD trial are: Nicholas Shaheen, MD, MPH, Professor of Medicine and Chief of Gastroenterology and Hepatology at the University of North Carolina, Chapel Hill; and John Hunter, MD, Mackenzie Professor of Surgery and Interim Dean at Oregon Health & Science University School of Medicine.
"Published international data suggest that the EndoStim system can successfully control symptoms and abnormal acid exposure in the esophagus and significantly improve patients' quality of life with minimal side effects," commented Dr. Shaheen. "This is why we anxiously await the outcomes of the LESS GERD trial."
"The less invasive and less disruptive design of the EndoStim technology has the potential to change the care of the patient with medication-resistant gastroesophageal reflux," said Dr. Hunter. "I'm thrilled to have the opportunity to lead this trial along with a renowned group of investigators."
First patient enrolled and treated in Los Angeles
The first patient underwent the EndoStim procedure this week at the Keck School of Medicine of the University of Southern California in Los Angeles by John Lipham, MD, Chief of the Division of Upper GI and General Surgery and site principal investigator.
"There is a significant need for an effective and less invasive procedure for reflux that will potentially help a large number of patients unsatisfied with current therapy options," said Dr. Lipham. "I have been following EndoStim's clinical outcomes in Europe for the last few years and I am thrilled to be part of introducing this exciting therapy in the U.S."
EndoStim's LES Stimulation System is a minimally-invasive implantable device designed to provide long-term reflux control by restoring normal esophageal function through neurostimulation. The therapy directly targets the patient's weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus, often the underlying cause of reflux.
About the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) Trial
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. 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.
Patients seeking information on the trial should visit: www.lessgerd.com.
EndoStim is a medical device company based in St. Louis, Missouri, and Nijmegen, The Netherlands, developing and commercializing a revolutionary treatment for GERD. The EndoStim LES Stimulation System is CE Marked for patients with gastroesophageal reflux disease with symptom duration of six months or longer, and is available in a number of countries throughout Europe, Latin America, and Asia Pacific. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only. For more information, visit www.endostim.com.
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