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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
EndoGastric Solutions
Sandhill Scientific Inc.
Crospon
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00857597
First received: March 4, 2009
Last updated: April 17, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Endoscopy GERD
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • GERD symptoms [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PPI usage [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
  • Lower esophageal acid exposure [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
  • Healed reflux esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857597

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Blair A Jobe, MD     412-623-2025     jobeba@upmc.edu    
Contact: Bart PL Witteman, MD     412-623-3073     bplwitteman@gmail.com    
Principal Investigator: Blair A Jobe, MD            
Netherlands
University Hospital Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Nicole D Bouvy, MD, PhD     +31433876543 ext 6883     n.bouvy@mumc.nl    
Contact: Bart PL Witteman, MD     +31433876543     bplwitteman@gmail.com    
Principal Investigator: Nicole D Bouvy, MD, PhD            
Sponsors and Collaborators
University of Pittsburgh
EndoGastric Solutions
Sandhill Scientific Inc.
Crospon
Investigators
Principal Investigator: Blair A Jobe, MD University of Pittsburgh
Principal Investigator: Nicole D Bouvy, MD, PhD University Hospital Maastricht, The Netherlands
  More Information

No publications provided

Responsible Party: Blair A Jobe, MD, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00857597     History of Changes
Other Study ID Numbers: D00668-01C
Study First Received: March 4, 2009
Last Updated: April 17, 2009
Health Authority: United States: Institutional Review Board
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University of Pittsburgh:
GERD
endoscopic
fundoplication
 Proton Pump Inhibitors
heartburn
anti-reflux surgery

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Pantoprazole
 Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013