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

March 28, 2018 updated by: University of Pittsburgh

A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Nexium
  • Rabeprazole
  • Prevacid
  • Aciphex
  • Prilosec
  • Losec
  • Pariet
  • Esomeprazole
  • Omeprazole
  • Protonix
  • Pantozol
  • Lansomeprazole
  • Pantoprazole
  • Dakar
  • Lanso
  • Lanzor
  • Prezal
  • Lanzol
  • Logastric
  • Zurcal
  • Zurcale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GERD symptoms
Time Frame: Baseline
Baseline
GERD symptoms
Time Frame: 6 month follow-up
6 month follow-up
GERD symptoms
Time Frame: 12 month follow-up
12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPI usage
Time Frame: at 0, 6 and 12 month follow- up
at 0, 6 and 12 month follow- up
Lower esophageal acid exposure
Time Frame: at 0, 6 and 12 month follow- up
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)
at 0, 6 and 12 month follow- up
Rate of adverse events
Time Frame: at 0, 6 and 12 month follow- up
at 0, 6 and 12 month follow- up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

EndoGastric Solutions
Sandhill Scientific
Crospon

Investigators

  • Principal Investigator: Blair A Jobe, MD, University of Pittsburgh Medical Center
  • Principal Investigator: Nicole D Bouvy, MD, PhD, University Hospital Maastricht, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D00668-01C
  • PRO08110069 (Other Identifier: University of Pittsburgh)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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