Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01647958

The EndoGastric Solutions TEMPO Trial — TEMPO  

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:
Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01647958
Study type Interventional
Source EndoGastric Solutions
Contact
Status Completed
Phase N/A
Start date June 1, 2012
Completion date December 1, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT03561883 - Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs) Phase 3
Completed NCT01406210 - RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol N/A
Completed NCT02555852 - Proton Pump Inhibitors and Risk of Community-acquired Pneumonia N/A
Terminated NCT01327963 - Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study N/A
Completed NCT01570842 - Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury N/A
Completed NCT02141711 - TAK-438 - Safety, Blood Levels & Effects of Repeated Doses Phase 1
Terminated NCT00587275 - Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI Phase 2
Completed NCT00228527 - Esomeprazole for Treatment of GERD in Pediatric Patients Phase 4
Completed NCT00261300 - Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708) Phase 3
Recruiting NCT04506593 - Indiana University Gastrointestinal Motility Diagnosis Registry
Completed NCT00795093 - Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US N/A
Completed NCT00394472 - Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients Phase 2
Completed NCT00574925 - Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients Phase 4
Terminated NCT02749071 - An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux N/A
Recruiting NCT01129713 - Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE. Phase 1/Phase 2
Completed NCT00734747 - Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD) Phase 3
Completed NCT00312806 - Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341) Phase 3
Not yet recruiting NCT05579587 - Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
Recruiting NCT02366169 - Medigus Ultrasonic Surgical Endostapler (MUSE) Registry N/A
Completed NCT01374074 - Racial Disparity in Barrett's Esophagus N/A