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Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment (TvP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of Pittsburgh.
Recruitment status was:  Recruiting
EndoGastric Solutions
Sandhill Scientific
Information provided by:
University of Pittsburgh Identifier:
First received: March 4, 2009
Last updated: April 17, 2009
Last verified: April 2009
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).

Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Procedure: Transoral Incisionless Fundoplication
Drug: Proton Pump Inhibitors; active control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • GERD symptoms [ Time Frame: at 0, 6 and 12 month follow- up ]

Secondary Outcome Measures:
  • 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 ]
  • Healed reflux esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ]
  • Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ]

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EsophyX 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
Active Comparator: Proton Pump Inhibitors 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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00857597

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
University of Pittsburgh
EndoGastric Solutions
Sandhill Scientific
Principal Investigator: Blair A Jobe, MD University of Pittsburgh
Principal Investigator: Nicole D Bouvy, MD, PhD University Hospital Maastricht, The Netherlands
  More Information

Responsible Party: Blair A Jobe, MD, University of Pittsburgh Medical Center Identifier: NCT00857597     History of Changes
Other Study ID Numbers: D00668-01C 
Study First Received: March 4, 2009
Last Updated: April 17, 2009

Keywords provided by University of Pittsburgh:
Proton Pump Inhibitors
anti-reflux surgery

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 20, 2017