EndoGastric Solutions announced that patient enrollment has been completed for its Transoral Incisionless Fundoplication (TIF) versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD symptoms (TEMPO) trial.
The controlled, multi-center, open-label, prospective and randomized study has enrolled 51 patients to assess the efficacy and safety of TIF procedure performed with the company’s EsophyX device as compared to PPI therapy.
The FDA-cleared device, which is inserted transorally with visual guidance from an endoscope, is designed to reconstruct the gastroesophageal valve, thus restoring its competency and reestablishing the barrier to reflux.
The enrolled patients are randomized in a two-to-one ratio, in which 34 patients were treated with TIF and 17 remained on PPI therapy, according to the company.
Primary endpoint includes elimination or improvement, while secondary endpoints include esophageal acid exposure time, PPI usage, healing of esophagitis and patient satisfaction.
Reston Surgical Associates spokesperson and trial principal investigator Dr Karim Trad said results so far are promising for both the patients and surgeons.
"Troublesome symptoms despite medical therapy are an ongoing clinical challenge that represents an unmet need in the treatment of GERD," Trad added.
EndoGastric Solutions president and CEO Mike Kleine said the company is looking forward to report initial findings of TEMPO trial.
"We believe that this trial will further demonstrate the value of TIF in providing relief to patients who suffer from medically refractory GERD symptoms," Kleine added.