Significantly More TIF/Placebo Patients Experienced Elimination of Troublesome Regurgitation as Compared to Sham/PPI Patients
SAN MATEO, Calif.–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<0.001).
“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. Abstract is available here.
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up into the esophagus, causing heartburn and possible injury to the esophageal lining. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 23 million people two or more times per week in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum dose usage of prescription medications has been linked to a variety of other health complications.
About the EsophyX® device
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted through the patient’s mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
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.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in San Mateo, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.
1Vakil N, Van zanten SV, Kahrilas P, Dent J, Jones R. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-20.
2Redberg, MD, R.F; Sham Controls in Medical Device Trials; N Engl J Med. 2014 Sep 4;371(10):892-3. http://www.nejm.org/doi/full/10.1056/NEJMp1406388
EndoGastric Solutions, Inc.
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Phone: 646-871-8482 (direct)
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia <2 cm in size in patients with symptomatic chronic gastroesophageal reflux disease.