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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

Tracking Information
First Submitted Date  ICMJE March 4, 2009
First Posted Date  ICMJE March 6, 2009
Last Update Posted Date March 30, 2018
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • GERD symptoms [ Time Frame: Baseline ]
  • GERD symptoms [ Time Frame: 6 month follow-up ]
  • GERD symptoms [ Time Frame: 12 month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2009)
GERD symptoms; a ≥ 50% improvement will represent a clinically significant improvement. Treatment success will be defined by a significantly (p < 0.05) higher number of patients with ≥ 50% improvement in the TIF group vs. PPI group. [ Time Frame: at 0, 6 and 12 month follow- up ]
Change History Complete list of historical versions of study NCT00857597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • 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 ]
  • Esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ]
    Percentage of Participants with Esophagitis (Los Angeles classification scale)
  • Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2009)
  • PPI usage; Treatment success will be defined by PPI discontinuation or a significantly higher number of patients (p<0,05) that has a reduction from "daily" to "none" or "occasional". [ Time Frame: at 0, 6 and 12 month follow- up ]
  • Normalized acid exposure; Treatment success will be defined by a significantly (p < 0.05) higher number of patients with normalized acid exposure in the TIF group (OFF PPI) vs. PPI group (ON PPI). [ Time Frame: at 0, 6 and 12 month follow- up ]
  • Healed reflux esophagitis; Healing of esophagitis will represent a clinically significant improvement. Treatment success will be defined by a significantly (p < 0.05) higher number of patients with healed esophagitis in the TIF group vs. PPI group. [ Time Frame: at 0, 6 and 12 month follow- up ]
  • Rate of (serious)adverse event (AE & SAE), gastro intestinal symptoms. Equivalence in safety will be defined by not statistically different (p > 0.05) scores and AE and SAE occurrence rate between the TIF group vs. PPI group. [ Time Frame: at 0, 6 and 12 month follow- up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Official Title  ICMJE A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease (GERD)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: EsophyX
    Intervention: Procedure: Transoral Incisionless Fundoplication
  • Active Comparator: Proton Pump Inhibitors
    Intervention: Drug: Proton Pump Inhibitors; active control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2009)
120
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00857597
Other Study ID Numbers  ICMJE D00668-01C
PRO08110069 ( Other Identifier: University of Pittsburgh )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • EndoGastric Solutions
  • Sandhill Scientific
  • Crospon
Investigators  ICMJE
Principal Investigator: Blair A Jobe, MD University of Pittsburgh Medical Center
Principal Investigator: Nicole D Bouvy, MD, PhD University Hospital Maastricht, The Netherlands
PRS Account University of Pittsburgh
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP