Six-month results of the first-ever sham and placebo-controlled study of a transoral endoscopic procedure for GERD presented at American College of Gastroenterology (ACG) 2014 Annual Scientific Meeting
SAN MATEO, Calif. (Oct. 20, 2014)–EndoGastric Solutions (EGS) today announces six-month results from world’s first-ever randomized, sham- and placebo-controlled prospective clinical study of the TIF® procedure; the data demonstrates that the TIF procedure is more effective than twice daily proton pump inhibitor (PPI) drug at eliminating troublesome regurgitation in patients with chronic gastroesophageal reflux disease (GERD).
The data from the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) will be presented at the ACG 2014 Annual Scientific Meeting and Postgraduate Course in Philadelphia, PA during “Plenary Session 1: Esophagus” starting at 2:15 PM EST Tuesday, October 21, 2014 by Peter Kahrilas, M.D., Professor of Medicine-Gastroenterology, Northwestern University a co-principal investigator.
Significantly more patients who underwent the TIF procedure and then received an ongoing course of placebo medication, reported elimination of troublesome regurgitation after six months compared to patients randomized to the control arm, who underwent a sham procedure and continued to take double dose PPI (omeprazole) medical therapy.
In addition, the TIF procedure was associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control. Patients in both groups were blinded to therapy during follow-up and were assessed at 2, 12 and 26 weeks. At the 6 month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.
“Based on the robust, sham controlled trial design, we believe the TIF procedure is an option for appropriately selected GERD patients who suffer from troublesome regurgitation despite PPI therapy,” Dr. Kahrilas said. “The TIF procedure is best suited for patients with only a small or no detectible hiatal hernia.”
“Tens of thousands of long-term GERD sufferers fall into a treatment gap where they are no longer able to control their symptoms with lifestyle changes and medical therapy but aren’t prepared to undergo more invasive surgery,” said John Hunter, M.D., Mackenzie Professor & Chairman of Surgery, Oregon Health & Science University and co-principal investigators.
“The TIF procedure may address this treatment gap by offering patients a less invasive option to treat the underlying anatomical cause of their disease, improving their regurgitation symptoms, quality of life, and reducing esophageal exposure to acid,” concluded Hunter.
“The presentation of the six-month RESPECT data highlights our dedication to high-quality, controlled clinical research and represents a significant milestone for EGS and the entire field of advanced transoral procedural therapies,” said Skip Baldino, EGS President and CEO. “We would like to thank Dr. Kahrilas, Dr. Hunter and all of the other investigators for conducting this robust study.”
“Patients in this blinded sham-controlled study deserve special recognition for their willingness to enroll not knowing which treatment arm they were assigned to until 6 months after their treatment protocol began,” continued Baldino. “We express our deepest gratitude from EGS and the scientific community for their participation in this important study.”
Nine participating academic and community centers enrolled and treated 129 patients as part of the RESPECT study. The investigators, consisting of fifteen general surgeons and a gastroenterologist, will follow the patients for 12 months. Additional information about the RESPECT study can be found at www.clinicaltrials.gov.