EndoGastric Solutions has completed patient enrolment in its Transoral Incisionless Fundoplication (TIF) versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD symptoms (Tempo ) trial.
The objective of the controlled, multi-centre, open-label, prospective and randomised study is to assess the efficacy and safety of TIF procedure performed with the company’s EsophyX device, as compared to PPI therapy.
With visual guidance from an endoscope, the FDA-cleared device is inserted transorally to reconstruct the gastroesophageal valve, thus restoring its competency and reestablishing the barrier to reflux.
The study has enroled 51 patients with GERD symptoms, a history of daily PPI therapy for over six months, as well as a hiatal hernia of less than 2cm.
The enrolled patients were randomised in a two-to-one ratio, in which 34 patients were treated with TIF, and 17 remained on PPI therapy, according to the company.
Symptom elimination or improvement is the primary endpoint for the trial, while esophageal acid exposure time, PPI usage, healing of esophagitis and patient satisfaction are the secondary endpoints.
Reston Surgical Associates spokesperson and trial principal investigator Dr Karim Trad said initial results are promising for patients and surgeons.
"Troublesome symptoms despite medical therapy are an ongoing clinical challenge that represents an unmet need in the treatment of GERD," Trad said.
EndoGastric Solutions president and CEO Mike Kleine said the company is looking forward to reporting initial findings of the 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 said.