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by Chip Hennen Redwood City, CA (May 10, 2010) – EndoGastric Solutions (EGS), the recognized leader in the emerging field of Natural Orifice Surgery (NOS), today announced the launch of the TIF (Transoral Incisionless Fundoplication) Registry Study. The TIF Registry Study is a multicenter, prospective, non-randomized study that will investigate the safety and effectiveness of TIF procedures for the treatment of gastroesophageal reflux disease (GERD) in a broad range of patients in routine clinical practice. The registry will examine symptomatic and objective measures of effectiveness and will report all adverse events. The study will assess both typical GERD symptoms such as heartburn and atypical GERD manifestations such as persistent cough, laryngitis and asthma. The first six U.S. sites and nine investigators are enrolled in the registry. To qualify for participation in the study, TIF users are required to practice the most current techniques and must have completed a large number of cases with good clinical outcomes. As IRB approvals are received, additional sites will be added to a maximum of 10 sites. The following sites and investigators are starting enrollment:
"I see the TIF registry as an opportunity for our community hospital to share our results with other centers across the country,” explained Dr. Mavrelis, an advanced therapeutic endoscopist from Hobart, Indiana. “By sharing our results, we can continue to improve the technique. Our goal is to provide the best possible procedure to help those with heartburn and GERD who do not want to take lifelong medications." “TIF has been the catalyst for my antireflux surgery practice,” said Dr. Gunsberger, an osteopathic surgeon from Mesa, Arizona. “I have performed over 30 procedures since attending training a year ago. My technique has progressed and now includes laparoscopic hiatal hernia repair to enable TIF procedures for those patients with hiatal hernias larger than 2 cm. The TIF Registry will allow me to share the benefits of my experience and learn from other sites. I expect the TIF Registry data to confirm that TIF is a frontline surgical procedure for patients with moderate to severe GERD.” “A solid safety and effectiveness profile has already been established for the TIF procedure,” commented Michael Daniel, Vice President, Clinical and Regulatory Affairs at EndoGastric Solutions. This will be the largest TIF study and the largest study of any Natural Orifice Surgery (NOS) procedure to date. I expect the TIF registry data to demonstrate that excellent outcomes can be achieved reproducibly across multiple sites and diverse GERD patient populations. We expect to complete enrollment for 200 patients by the end of the year. At that point, we will consider expansion of the registry. Initial six month results will be reported.” "Launching the TIF Registry is an important milestone for EndoGastric Solutions,” said Thierry Thaure, President and Chief Executive Officer of EndoGastric Solutions. "The registry participants represent a broad cross section of physicians interested in bringing the TIF procedure to their GERD patients. Specifically, the investigators include general surgeons, osteopathic surgeons, and advanced therapeutic endoscopists. The registry data will be pivotal in the continued adoption of the TIF procedure and another important step toward establishing the procedure as standard of care.” For more information on the TIF Registry Study, please go to http://clinicaltrials.gov/ct2/show/NCT01118585?term=tif+registry&rank=1
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