A Phase 3 interventional study of Transoral Incisionless Fundoplication and Proton Pump Inhibitors; active control in Gastroesophageal Reflux Disease (GERD), sponsored by University of Pittsburgh. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-30.
Sponsored by University of Pittsburgh · Phase 3, Interventional, and Treatment
The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Transoral Incisionless Fundoplication
Drug: Proton Pump Inhibitors; active control
The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.
Also known as: TIF procedure, ELF procedure, Endoluminal fundoplication, Endoscopic fundoplication
Proton Pump Inhibitors; active control
Also known as: Esomeprazole, Lansomeprazole, Omeprazole, Pantoprazole, Rabeprazole, Nexium, Prevacid, Dakar, Lanso, Lanzor, Prezal, Lanzol, Prilosec, Losec, Logastric, Protonix, Zurcal, Pantozol, Zurcale, Aciphex, Pariet
GERD symptoms
Time frame: Baseline
GERD symptoms
Time frame: 6 month follow-up
GERD symptoms
Time frame: 12 month follow-up
PPI usage
Time frame: at 0, 6 and 12 month follow- up
Lower esophageal acid exposure
Time frame: at 0, 6 and 12 month follow- up
Esophagitis
Percentage of Participants with Esophagitis (Los Angeles classification scale)
Time frame: at 0, 6 and 12 month follow- up
Rate of adverse events
Time frame: at 0, 6 and 12 month follow- up
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh