EndoGastric Solutions (EGS) announces that Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute and the most prominent journal in the field of gastrointestinal disease, has published landmark data from the first-ever blinded, randomized, sham- and placebo-controlled clinical study of the Transoral Incisionless Fundoplication (TIF) procedure.
Of the 87 patients who were randomly assigned to the group that underwent the TIF procedure and then received an ongoing course of placebo medication, after six months 67% reported elimination of troublesome regurgitation per Montreal consensus criteria.1 Meanwhile, of the 42 patients who were randomized to undergo sham surgery and then continued to take optimized doses of proton pump inhibitor (PPI) regiment (omeprazole), 45% reported elimination of the same symptom (p=0.023).
"Consistent with the Montreal definition, the RESPECT (Randomized EsophyX vs. Sham/Placebo Controlled Trial) study enrolled patients with troublesome regurgitation and objectively confirmed gastroesophageal reflux disease (GERD). This is the first ever randomized blinded trial to focus exclusively on regurgitation," said John Hunter, MD, Mackenzie Professor & Chairman of Surgery, Oregon Health & Science University and co-principal investigator.
"The data demonstrates that the TIF procedure is more effective than optimized PPI drugs at eliminating troublesome regurgitation in selected chronic GERD patients with hiatal hernia less than 2 cm," continued Dr. Hunter.
In addition, 77% of the TIF patients had healed their reflux esophagitis. TIF procedure was also associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control (p
"In other studies, the therapeutic gain of PPI therapy over placebo for the control of regurgitation is modest. Data from this well designed study suggest that the TIF procedure provides an attractive option to manage troublesome GERD symptoms, especially considering a notable absence of troublesome dysphagia and bloating after the TIF procedure," said Peter Kahrilas, MD, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.
"We are pleased to have the RESPECT data published in Gastroenterology," said Skip Baldino, President and CEO of EndoGastric Solutions. "In a recent New England Journal of Medicine editorial,2 the medical device industry was challenged to conduct more sham controlled trials in order to validate novel procedures and devices; we are thrilled that RESPECT has met this most rigorous scientific test."
Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.
Eight participating academic and community centers screened 696 patients of which 129 were enrolled into the RESPECT study. The investigators, consisting of 15 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.
About Transoral Incisionless Fundoplication (TIF) procedure for reflux
Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.
The TIF procedure has an established safety and efficacy profile with more than 16,000 patients treated worldwide. For more information, visit www.GERDHelp.com.