EndoGastric Solutions (EGS) has enrolled and treated first patient in the randomized EsophyX device vs. sham/placebo controlled trial (RESPECT study).
The trial was designed to generate the first US Level 1 evidence supporting transoral incisionless fundoplication (TIF) surgery.
TIF surgery with the EsophyX device provides incisionless solution to correct the root cause of gastro esophageal reflux disease (GERD).
Inserted through the patient’s mouth, under visual guidance of an endoscope, the EsophyX device is used to construct a durable anti-reflux valve and tighten the lower esophageal sphincter, re-establishing a barrier to reflux and restoring the competency of the gastro esophageal junction.
Under the trial, 120 patients will be randomized between TIF and sham, and omeprazole and placebo over a 12-month period.
Randomization will occur in a two-to-one ratio, with 80 patients receiving surgery and 40 receiving sham.
Oregon Health & Science University Surgery chairman John Hunter said the RESPECT trial is the natural next step in the development of evidence supporting TIF.
Northwestern University Medicine-Gastroenterology professor Peter Kahrilas said 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.
EGS Regulatory and Clinical Affairs VP Michael Daniel said RESPECT, with an aim to validate transoral fundoplication, will cement transoral fundoplication as the standard of care for appropriately-selected GERD patients.