The EndoGastric Solutions TEMPO Trial
This trial is active, not recruiting.
|Condition||gastroesophageal reflux disease (gerd)|
|Treatment||esophyx system with serosafuse fasteners|
|Start date||June 2012|
|End date||October 2015|
|Trial size||65 participants|
|Trial identifier||NCT01647958, D01292|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
GERD symptom elimination or clinically significant improvement evaluated by GERD-HRQL, RSI and RDQ.
time frame: 6 months
Elimination of daily bothersome GERD symptoms
time frame: 60 months
time frame: 60 Months
Normalization of esophageal acid exposure
time frame: 36 Months
Healing or reduction of esophagitis.
time frame: 36 Months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: 1. Age 18-80 years; 2. GERD for > 1 year; 3. History of daily PPIs for > 6 months; 4. At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs; 5. Hill grade I and II at gastroesophageal junction; 6. Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing; 7. Willingness to undergo pH testing; 8. Willingness to cooperate with the postoperative diet; 9. Availability for follow-up visits at 6, 12, 24, and 36 months; 10. Willingly and cognitively signed inform consent Exclusion Criteria: 1. BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse dimension; 2. Esophagitis grade C and D; 3. Barrett's esophagus > 2 cm; 4. Esophageal ulcer; 5. Fixed esophageal stricture or narrowing; 6. Portal hypertension and/or varices; 7. Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis; 8. Gastroparesis; 9. Coagulation disorders; 10. History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis; 11. Pregnancy or plans of pregnancy in the next 12 months; 12. Enrollment in another device or drug study that may confound the results
|Official title||Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms|
|Principal investigator||Karim Trad, MD, FACS|
|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.|
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