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Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

NCT01110811 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-03-06

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 proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

Conditions

  • Gastroesophageal Reflux Disease
  • Hiatal Hernia

Interventions

PROCEDURE

Transoral Incisionless Fundoplication (TIF)

The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.

Sponsors & Collaborators

  • EndoGastric Solutions

    lead INDUSTRY

Principal Investigators

  • Lars Lundell, M.D. · Karolinska University, Huddinge Hospital, Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-09-30
Completion
2018-12-31

Countries

  • Belgium
  • France
  • Sweden

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 NCT01110811 on ClinicalTrials.gov