Data shows positive results from 192 patients followed up to 12-months at multiple centers
SAN MATEO, Calif. – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that Karim Trad, MD, presented a review of data from EndoGastric Solutions’ multi-center, randomized, controlled TEMPO and RESPECT studies for the TIF procedure at SAGES 2015, the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. SAGES runs from April 15 to 18, 2015 in Nashville.
“Taken together, these two well-designed, randomized controlled trials highlight the significant benefits of the TIF procedure in well-selected GERD patients with incomplete symptom control on high-dose PPI therapy,” said Dr. Trad, surgeon at George Washington University School of Medicine and Health Sciences and the principal investigator of the TEMPO study who also participated in the RESPECT study.
“The TIF procedure is capable of dramatically eliminating GERD symptoms, healing esophagitis and improving quality of life with minimal or no side effects. The recent multi-center study data has proven this incisionless, endoluminal approach as more effective than PPI drugs at eliminating troublesome regurgitation in a sub-group of chronic GERD patients, which is a significant achievement for this disease,” concluded Dr. Trad.
Dr. Trad reviewed the results of the RESPECT and TEMPO studies for his presentation, “Endolumenal Therapies are the Best Option,” during a Half-Day Postgraduate Course, Advances in Foregut Surgery that ran from 7:30 a.m. CT to noon CT on Wednesday, April 15.
About the RESPECT Study
RESPECT is the first-ever blinded, randomized, sham- and placebo-controlled, multicenter clinical study of the Transoral Incisionless Fundoplication (TIF®) procedure. As previously reported, 67% of the 87 patients who were randomly assigned to the group that underwent the TIF procedure and then received an ongoing course of placebo medication reported elimination of troublesome regurgitation per Montreal consensus criteria after six months.1 Meanwhile, of the 42 patients who were randomized to undergo sham surgery and then continued an optimized dose of proton pump inhibitor (PPI) regimen (omeprazole), 45% reported elimination of the same symptom (p=0.023).
In addition, 77% of the TIF patients had healed their reflux esophagitis. The TIF procedure was also associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control (p<0.001).
About the TEMPO Study
TEMPO is a prospective, randomized, multicenter clinical trial during which all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm. Seventy-seven percent of patients in original treatment arm (n-39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Esophagitis, or inflammation of the esophagus, remained healed in 100% of the patients in the original treatment arm.2
Over 50 peer-reviewed studies of the TIF procedure have been published in medical journals with results from over 800 unique patients treated.