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).
[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.
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.
About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.
Over 25,000 TIF procedures have been performed worldwide. More than 140 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.
For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.
About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.
The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.
About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.
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