Randomized, head-to-head study represents most comprehensive effort to date to compare Transoral Incisionless Fundoplication (TIF®) outcomes to sham surgery and PPI therapy in patients with GERD
Company also announces 14,000 patients treated with TIF procedure since company was founded 10 years ago
SAN MATEO, Calif. (Oct. 8, 2013)–EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), announced today that enrollment for the RESPECT study (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) is complete and has surpassed the company’s original target of 120 patients.
EGS designed the RESPECT study to generate additional Level 1 evidence supporting the transoral incisionless fundoplication (TIF®) procedure as a treatment for GERD. There were two treatment arms in the study. Patients were randomized, in a two-to-one ratio, to either the treatment group which received the TIF procedure followed by an ongoing course of placebo medication, or the control group which underwent a sham procedure followed by administration of proton pump inhibitor (PPI, omeprazole) medical therapy.
“We are thrilled to complete enrollment and primary treatment of over 120 patients in the RESPECT trial, which compares PPI with TIF, in a randomized, blinded fashion. Only after 6 months are patients able to know whether or not they have had the TIF performed,” said John Hunter, M.D., Mackenzie Professor & Chairman of Surgery, Oregon Health & Science University. “We are excited to ‘un-blind’ the data, and begin to determine in a very objective fashion the benefit that the TIF procedure might provide when compared to PPIs.”
Dr. Hunter and Peter Kahrilas, M.D., Professor of Medicine-Gastroenterology, Northwestern University are co-principal investigators in the trial. RESPECT is the first randomized trial evaluating transoral fundoplication against both a sham procedure and PPI therapy, and includes PPI-dependent GERD patients suffering from breakthrough moderate-to-severe symptoms at least two to three times a week.
“GERD is a progressive disease that patients learn to manage with lifestyle changes and calibrated medication dosing. Once these treatment options are exhausted or when they prove unsatisfying, procedural interventions or surgery become their best hope to control symptoms,” said Dr. Kahrilas. “The RESPECT study will help define the appropriate selection criteria for patients who will most likely benefit from the TIF procedure and experience an improvement in their quality of life.”
The primary goal of the study is to determine if at six-month follow up the TIF procedure leads to a clinically significant reduction in GERD symptoms, specifically “troublesome” regurgitation with or without heartburn as defined by the Montreal Consensus.[i] Investigators will also determine if the patients’ esophageal acid exposure has normalized and measure the degree to which reflux esophagitis has healed after six months and after one year.
“Conducting a randomized trial that includes a sham treatment arm is a significant endeavor. We would like to thank all the individuals who have worked so hard to make this trial happen,” said Michael Kleine, President and CEO EndoGastric Solutions. “We have an enormous debt of gratitude to the many patients who entered this trial. Their willingness to participate in a study despite uncertainty of their initial treatment is to be commended.”
Nine participating U.S. hospitals have enrolled and treated 129 patients since the RESPECT study began in June 2011. The investigators, consisting of fifteen general surgeons and a gastroenterologist, will follow the patients for 12 months. Initial reported outcomes may begin to be presented at scientific meetings as early as 2014.
Additional information about the RESPECT study can be found at www.clinicaltrials.gov.
Separately, EGS celebrated its 10th anniversary on May 15, 2013. On that day in 2003, Stefan Kraemer, M.D. formed the company with the vision that the gastroesophageal junction could be reconstructed from within the digestive tract using an endoluminal approach. In the years since, the resulting EsophyX device and TIF procedure have been used to treat GERD in more than 14,000 patients worldwide (12,500 in the United States).
Gastroesophageal Reflux Disease (GERD) is a condition caused by anatomical changes where the muscle at the base of the esophagus relaxes between swallows, allowing corrosive stomach acid to wash back up into the esophagus. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. The cells that line the stomach consists of protective mucus that protect it from erosion, but the lining of the esophagus does not share these resistant features and stomach acid can damage it.
GERD is the most common gastrointestinal-related diagnosis given 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. Patients implement these recommendations trying to manage their symptoms and the quality of their lives becomes negatively impacted by these recommendations.
About EsophyX® and Transoral Incisionless Fundoplication (TIF®)
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. The TIF procedure is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD). The TIF procedure is based on traditional surgical principles and offers similar effectiveness to a surgical repair with the safety profile of an incision-free approach. To date, more than 14,000 patients have been 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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[i] Vakil 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.