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

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ClinicalTrials.gov Identifier: NCT00857597
Recruitment Status : Terminated (Study was terminated after unplanned interim analysis of single centre data and results were reported)
First Posted : March 6, 2009
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
EndoGastric Solutions
Sandhill Scientific
Crospon
Information provided by (Responsible Party):
University of Pittsburgh

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel 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
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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



Primary Outcome Measures :
  1. GERD symptoms [ Time Frame: Baseline ]
  2. GERD symptoms [ Time Frame: 6 month follow-up ]
  3. GERD symptoms [ Time Frame: 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. Esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ]
    Percentage of Participants with Esophagitis (Los Angeles classification scale)

  4. Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ]


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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

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
Netherlands
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
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

Additional Information:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00857597     History of Changes
Other Study ID Numbers: D00668-01C
PRO08110069 ( Other Identifier: University of Pittsburgh )
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: October 2016

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