We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

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: NCT00857597
Recruitment Status : Unknown
Verified April 2009 by University of Pittsburgh.
Recruitment status was:  Recruiting
First Posted : March 6, 2009
Last Update Posted : April 20, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Procedure: Transoral Incisionless Fundoplication Drug: Proton Pump Inhibitors; active control Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. PPI usage [ Time Frame: at 0, 6 and 12 month follow- up ]
  2. Lower esophageal acid exposure [ Time Frame: at 0, 6 and 12 month follow- up ]
  3. Healed reflux esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ]
  4. Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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
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

Responsible Party: Blair A Jobe, MD, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00857597     History of Changes
Other Study ID Numbers: D00668-01C
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009

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
Esomeprazole
Pantoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action