EndoGastric Solutions has started TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) trial.
The controlled, multi-center, open-label, prospective, randomized study, which will enroll 51 patients, is designed to assess the safety and effectiveness of Transoral Incisionless Fundoplication (TIF) procedure performed using the company's EsophyX device, as compared to PPI therapy.
The patients enrolled over a three-month period will be randomized in a two-to-one ratio, in which 34 patients will be treated with TIF and 17 will remain on PPI therapy.
The study will evaluate various endpoints including improvement in GERD-related symptoms, esophageal acid exposure time, PPI use, and patient satisfaction.
Following initial treatment, follow-up assessments will occur at two weeks as well as three-, six-, and twelve-months.
TEMPO trial principal investigator and Reston Surgical Associates spokesperson Karim Trad said, "I believe that TIF can treat these symptoms and that this trial will reframe TIF in its rightful context by comparing outcome data to PPIs rather than to laparoscopic Nissen surgery."
EndoGastric Solutions president and CEO Mike Kleine said, "With the addition of Level I evidence for TIF, we will demonstrate that our technology is an appropriate therapy for the millions of GERD patients who, in the past, have had to choose between long-term medical therapy and more invasive surgery."
