Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: TEMPO TIF Transoral Incisionless Fundoplication EsophyX System refractory symptoms proton pump inhibitors EndoGastric Solutions EGS Acid Reflux Heartburn Regurgitation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 65
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Detailed description:
The objective of this study is to assess the efficacy and safety of TIF performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic GERD patients with medically refractory GERD symptoms other than heartburn.

Primary hypothesis: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 6-month follow-up. Secondary hypotheses: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 12-, 24-, 36-, 48- and 60-month follow-up. The majority of surgical patients will have normalized or 50% improved esophageal acid exposure compared to baseline at 6-month follow-up. The majority of surgical patients will be completely off PPIs at 6-, 12-, 24-, 36-, 48- and 60-month follow-up compared to baseline. The majority of crossover patients will be completely off PPIs at 6-, 18-, 30-, 42- and 54-month follow-up compared to baseline. A statistically greater proportion of crossover patients treated with TIF will be free of daily bothersome symptom(s) or will experience clinically significant improvement at 6-, 18-, 30-, 42- and 54-month follow-up.

Arms:
arm 1: Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. arm 2: Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial. Patients will be offered TIF crossover procedure upon completion of month-6 follow-up visit.

Interventions: intervention 1: EsophyX System with SerosaFuse fasteners intervention 2: PPI
Intervention descriptions: intervention 1: Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners intervention 2: Control Arm participants will take maximum standard dose of PPI during Initial Study period

Protocol document: