The EndoGastric Solutions TEMPO Trial (TEMPO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01647958|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease (GERD)||Device: EsophyX System with SerosaFuse fasteners||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||December 2017|
Experimental: Treatment Arm
Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.
Device: EsophyX System with SerosaFuse fasteners
Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication
No Intervention: Control
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.
- GERD symptom elimination or clinically significant improvement evaluated by GERD-HRQL, RSI and RDQ. [ Time Frame: 6 months ]Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPIs as evaluated by the disease specific and validated instruments: (1) GERD-Health-Related Quality of Life (HRQL) questionnaire (2) Reflux Symptom Index (RSI) and (3) Reflux Disease Questionnaire (RDQ).
- Elimination of daily bothersome GERD symptoms [ Time Frame: 60 months ]Elimination of daily bothersome GERD symptoms as measured by scores of ≤2 for each GERD-HRQL question or RSI questions.
- PPI discontinuation [ Time Frame: 60 Months ]Elimination of daily bothersome GERD symptoms as measured by complete discontinuation of PPI therapy at 12-, 24-, 36-, 48- and 60-month follow-up.
- Normalization of esophageal acid exposure [ Time Frame: 36 Months ]Elimination of moderate to severe regurgitation with intensity reduced to one day a week as measured by RDQ or clinically significant improvement defined as ≥ 50% reduction in total scores at 12-, 24-, and 36-month follow-up.
- Healing or reduction of esophagitis. [ Time Frame: 36 Months ]Elimination of daily bothersome GERD symptoms as measured by healing or reduction of esophagitis.
- PPI discontinuation--crossover patients [ Time Frame: 54 months ]Elimination of daily bothersome GERD symptoms in crossover patients as measured by discontinuation of PPI therapy at 6-, 18-, 30-, 42- and 54-month follow-up.
- Elimination of daily bothersome GERD symptoms in crossover patients [ Time Frame: 54 months ]Elimination of daily bothersome GERD symptoms in crossover patients as measured by scores of ≤2 for each GERD-HRQL question or RSI questions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647958
|United States, Washington|
|Redmond, Washington, United States, 98052|
|Principal Investigator:||Karim Trad, MD, FACS||Reston Surgical Associates|