Trial | NCT00857597  Report issue

Title

Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    60
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).
Study Started
Mar 31
2009
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Mar 30
2018

Procedure Transoral Incisionless Fundoplication

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.

  • Other names: TIF procedure, ELF procedure, Endoluminal fundoplication, Endoscopic fundoplication

Drug Proton Pump Inhibitors; active control

Proton Pump Inhibitors; active control

  • Other names: Esomeprazole, Lansomeprazole, Omeprazole, Pantoprazole, Rabeprazole, Nexium, Prevacid, Dakar, Lanso, Lanzor, Prezal, Lanzol, Prilosec, Losec, Logastric, Protonix, Zurcal, Pantozol, Zurcale, Aciphex, Pariet

EsophyX Experimental

Proton Pump Inhibitors Active Comparator

Criteria 

Inclusion Criteria:

Age 18-75 years
Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days)
On daily PPIs for > 1 year
Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs)
Normal or hypotonic LES resting pressure (5-40 mmHg)
Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
Signed informed consent

Exclusion Criteria:

BMI > 35
Hiatal hernia > 2 cm
Esophagitis grade D
Barrett's esophagus
Esophageal stricture
Esophageal ulcer
Esophageal motility disorder
Gastric motility disorder
Prior splenectomy
Gastric paralysis
Pregnancy (in females)
Immunosuppression
ASA > 2
Portal hypertension
Coagulation disorders
Previous antireflux procedure
Any other health condition, which the investigator believes would prevent the patient from completing the study
Lack of fluency in English
No Results Posted