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.
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 compose 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.
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.