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Enrolling by invitation NCT04306380

Transoral Incisionless Fundoplication Database Repository (TIF)

— Observational Gastroesophageal Reflux Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention, database study.
Who it may be relevant to
Registry conditions: Gastroesophageal Reflux Disease. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.

Detailed description

Collect patient information related to transoral incisionless fundoplication (TIF) done for gastroesophageal reflux disease. The database information with be used for research to assess trends improve patient care.

Interventions

  • Other no intervention, database study
    data collection from EMR for database

Primary outcome measures

  • GERD-Health Related Quality of Life Questionnaire (GERD_HRQL) [Time frame: baseline; 6,12,24 and 60 months]
  • RESQ-7 questionnaire [Time frame: baseline; 6,12,24 & 60 months]

Eligibility criteria

Inclusion criteria

  • Having a TIF procedure completed at Indiana University Health, University Hospital

Exclusion criteria

  • under 13 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Indiana University Hospital — Indianapolis

Identifiers

NCT: NCT04306380 · 2001738876

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗