REDWOOD CITY, Calif.--(TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) trial. TEMPO, the second in a series of randomized trials involving TIF, is designed to assess the safety and efficacy of the procedure—performed using EndoGastric Solutions’ EsophyX® device—as compared to PPI therapy to treat bothersome symptoms associated with chronic GERD.)--EndoGastric Solutions® (EGS), the leader in endoluminal treatment of Gastroesophageal Reflux Disease (GERD), today announced the start of the
The TEMPO trial is a prospective, controlled, multi-center, randomized, open-label comparative clinical study. Fifty-one patients will be enrolled over a three-month period and randomized in a two-to-one ratio, in which 34 patients are treated with TIF and 17 remain on PPI therapy. The study will evaluate a number of endpoints including improvement in GERD-related symptoms, esophageal acid exposure time, PPI use, and patient satisfaction. Follow-up assessments will occur at two weeks as well as three-, six-, and twelve-months following initial treatment.
“TEMPO is a well-designed study which directly tackles the basic choice facing many patients suffering from GERD: TIF now or PPIs for life?” said Dr. Karim Trad of Reston Surgical Associates in Reston, Virginia and Principal Investigator in the trial. “The patients being enrolled in this study are similar to those that we see every day in clinical practice. They are burdened with a variety of symptoms that are inadequately managed with medical therapy, and are looking for treatment alternatives. 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.”
Two patients have already been treated as a part of the TEMPO trial—the first by Dr. Trad and the second by Dr. William Barnes at Livingston Hospital and Healthcare Center in Salem, Kentucky.
“EGS is committed to building upon the existing body of data on TIF and, equally as important, advancing the scientific community’s understanding of less invasive treatments for GERD,” said Mike Kleine, President and CEO of EGS. “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.”
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. TIF is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD), a disease that affects over 60 million people in the U.S. Because TIF is rooted in traditional surgical principles and is minimally invasive, the procedure offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in Redwood City, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to utilize the most current wisdom in gastroenterology and surgery to develop procedures and products that address unmet needs in gastrointestinal diseases.