Prospective, Randomized Study Showed Durability of Clinical Outcomes in the TIF group and Improved Control of GERD symptoms in the Crossover Group
SAN MATEO, Calif. (Oct. 8, 2014)–EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), announces publication of one year results of the TEMPO randomized, crossover trial, which found that the Transoral Incisionless Fundoplication (TIF®) procedure achieved sustained elimination of all GERD symptoms and healing of esophagitis.
In the patients randomized to the TIF treatment group (n=39), 93% achieved elimination of troublesome regurgitation; 77% achieved global elimination of all atypical symptoms and regurgitation. Reflux esophagitis was healed in all 19 patients who presented with the erosive disease on PPI therapy before the TIF procedure. Ninety-seven percent of patients were off daily PPI therapy. All esophageal pH parameters were significantly reduced at 12-month follow-up, compared to baseline.
In the crossover (control) group (n=21), after six months of high-dose PPI therapy twice daily, only 5% (1/21) of patients reported global elimination of regurgitation and atypical symptoms; this proportion significantly increased to 65% (13/20) six months after these patients crossed over and had the TIF procedure. Additionally, 80% of the cross-over patients were off daily PPIs six months following the TIF procedure.
“Approximately 30-40% of GERD patients remain symptomatic on PPI therapy.” said Karim S Trad, MD TEMPO principal investigator and a surgeon at George Washington University School of Medicine and Health Sciences. “This randomized trial demonstrates the ability of the TIF procedure to provide dramatic symptomatic relief and healing of reflux esophagitis in patients who present with significant clinical challenges. Based on the results of this study, we can now offer these patients an endoluminal, less invasive approach to relieve their troublesome GERD symptoms.”
“We are thrilled that the results of this study have confirmed that the TIF procedure is significantly more effective than high-dose PPI therapy in relieving troublesome regurgitation and atypical GERD symptoms,” said Skip Baldino, EGS President and CEO. “This is the only incisionless procedure currently available in the US that reconstructs a defective gastroesophageal valve with an endoscopic approach that is supported by safety and effectiveness data from randomized trials.”
The primary outcome of TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial was elimination of daily troublesome regurgitation and atypical symptoms as evaluated by two validated instruments—Reflux Disease Questionnaire and Reflux Symptom Index; secondary outcomes included healing of esophagitis, normalization of esophageal acid exposure and PPI use in the TIF treated patients at 6 and 12 months.
The results were published in the BioMed Central (BMC) Gastroenterology. This data include results from 60 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. Abstract is available here.