REDWOOD CITY, Calif.--(Transoral Incisionless Fundoplication (TIF®) versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) clinical trial, which will generate U.S. Level I evidence for TIF. The trial is designed to assess the safety and efficacy of the TIF procedure 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 completion of enrollment in its
“We are delighted to complete enrollment in the TEMPO trial. Results so far are very promising for both the patients and surgeons”
“We are delighted to complete enrollment in the TEMPO trial. Results so far are very promising for both the patients and surgeons,” said Dr. Karim Trad of Reston Surgical Associates in Reston, Virginia and Principal Investigator in the trial. “Troublesome symptoms despite medical therapy are an ongoing clinical challenge that represents an unmet need in the treatment of GERD.”
More than 5% of the adult population in the United States suffers from daily GERD symptoms. For these patients, the predominant treatment therapy – PPIs – often provides inadequate symptom control. TEMPO is designed to assess the effectiveness of the TIF procedure in sufferers who experience GERD symptoms despite the use of PPIs.
“We are extremely pleased to have reached this significant milestone and look forward to reporting initial findings,” said Mike Kleine, President and CEO of EGS. “We believe that this trial will further demonstrate the value of TIF in providing relief to patients who suffer from medically refractory GERD symptoms.”
The TEMPO trial is a prospective, controlled, multi-center, randomized, open-label comparative clinical study. Fifty-one patients have been enrolled in the trial. Patients were randomized in a two-to-one ratio, in which 34 patients were treated with TIF and 17 remained on PPI therapy. The primary endpoint is symptom elimination or improvement. Secondary endpoints are esophageal acid exposure time, PPI usage, healing of esophagitis and patient satisfaction. Eligible patients were those who have objective evidence of GERD, a history of daily PPI therapy for over six months, and a hiatal hernia less than 2 centimeters. Additional information about the TEMPO trial can be found at www.clinicaltrials.gov and www.acidrefluxtrial.com.
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.