EndoGastric Solutions, a provider of Natural Orifice Surgery (NOS) devices, had launched Transoral Incisionless Fundoplication (TIF) Registry study. The study is expected to assess both typical gastroesophageal reflux disease (GERD) symptoms such as heartburn and typical GERD manifestations such as persistent cough, laryngitis and asthma.
EndoGastric Solutions said that 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 (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 first six US sites and nine investigators are enrolled in the registry. To qualify for participation in the study, TIF users are required to practice the 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.
Mavrelis, an advanced therapeutic endoscopist from Hobart, Indiana, said: “I see the TIF registry as an opportunity for our community hospital to share our results with other centers across the country. 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.”
Michael Daniel, vice president of clinical and regulatory affairs, at EndoGastric Solutions, said: “A solid safety and effectiveness profile has already been established for the TIF procedure. 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 enhanced 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.”
Thierry Thaure, president and chief executive officer of EndoGastric Solutions, said: “Launching the TIF Registry is an important milestone for 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.”