Investigator Team Led by Dr. John Hunter and Dr. Peter Kahrilas
Redwood City, CA (June 23, 2011) – EndoGastric Solutions (EGS), the leader in the emerging field of Natural Orifice Surgery (NOS), today announced that the first patient has been enrolled and treated in the RESPECT study (Randomized EsophyX vs. Sham/Placebo Controlled Trial).
The RESPECT trial was designed by co-principle investigators Dr. John Hunter, Chairman of Surgery, Oregon Health & Science University, and Dr. Peter Kahrilas, Professor of Medicine-Gastroenterology, Northwestern University. The first patient in the study was enrolled by Dr. Reginald Bell, Assistant Clinical Professor of Surgery, University of Colorado Health Sciences Center.
Designed to generate the first U.S. Level 1 evidence supporting transoral incisionless fundoplication (TIF) surgery, the study randomizes patients between TIF and sham, and omeprazole and placebo. One hundred and twenty patients will be enrolled over a 12-month period. Randomization will occur in a two-to-one ratio, with 80 patients receiving surgery and 40 receiving sham.
“TIF is the first transoral surgical procedure that adheres to the principles of anti-reflux surgery and has generated the evidence necessary to be considered an acceptable option for the treatment of GERD,” said Dr. Hunter. “The RESPECT trial is the natural next step in the development of evidence supporting TIF. I am also excited that thought leaders from surgery and gastroenterology throughout the United States are involved with the study. This type of collaboration is critical to progress in the treatment of reflux.”
“The RESPECT trial will enable us to make meaningful conclusions on the role of transoral fundoplication in the spectrum of GERD disease management,” commented Dr. Kahrilas. “Including sham and placebo components in the study provides a level of rigor never before incorporated in previous trials that will help establish the true therapeutic benefit of this increasingly popular therapy.”
Michael Daniel, Vice President of Regulatory and Clinical Affairs at EndoGastric Solutions added, “RESPECT is the most substantive clinical trial undertaken to date with the objective of validating transoral fundoplication. We are honored to have a group of participating investigators that have contributed so much to the science of GERD treatment. With their help, we believe that the trial will cement transoral fundoplication as the standard of care for appropriately-selected GERD patients.”
About EsophyX® and Transoral Incisionless Fundoplication (TIF®)
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. TIF is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD), a disease that affects over 60 million people in the U.S. Because TIF is rooted in traditional surgical principles and is minimally invasive, the procedure offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in Redwood City, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to utilize the most current wisdom in gastroenterology and surgery to develop procedures and products that address unmet needs in gastrointestinal diseases.