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Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

NCT00857597 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-30

No results posted yet for this study

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).

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

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.

DRUG

Proton Pump Inhibitors; active control

Proton Pump Inhibitors; active control

Sponsors & Collaborators

  • EndoGastric Solutions

    collaborator INDUSTRY

  • Sandhill Scientific

    collaborator INDUSTRY

  • Crospon

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Blair A Jobe, MD · University of Pittsburgh Medical Center

  • Nicole D Bouvy, MD, PhD · University Hospital Maastricht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00857597 on ClinicalTrials.gov