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Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

NCT01327963 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-12-03

Study results available
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Summary

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DEVICE

Transoral Incisionless Fundoplication

Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.

Sponsors & Collaborators

  • EndoGastric Solutions

    lead INDUSTRY

Principal Investigators

  • William Barnes, MD MBA FACS · Livingston Hospital and Healthcare Services Inc, CAH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

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 NCT01327963 on ClinicalTrials.gov