EndoGastric Solutions has initiated the TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) trial.
The controlled, multicentre, open-label, prospective, randomised study will enrol 51 patients to demonstrate the safety and effectiveness of transoral incisionless fundoplication (TIF) procedure performed using the company’s EsophyX device, as compared to PPI therapy.
The patients suffering with chronic gastroesophageal reflux disease (GERD), enrolled over a three-month period, will be randomised in a two-to-one ratio, in which 34 patients will be treated with TIF and 17 will remain on PPI therapy.
The endpoints of the study include 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.
Karim Trad, TEMPO trial principal investigator and Reston Surgical Associates spokesperson, said the patients being enrolled in the study 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," Trad added.
As part of the TEMPO trial, two GERD patients have already been treated by Trad and William Barnes at Livingston Hospital and Healthcare centre in Salem, Kentucky, US.
Mike Kleine, EndoGastric Solutions president and CEO, 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."