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Enrolling by Invitation

NCT Number: NCT04306380

Transoral Incisionless Fundoplication Database Repository (TIF)

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

Enrolling by Invitation

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • under 13 years of age

Treatment and study plan

no intervention, database study

Other

data collection from EMR for database

Primary outcomes

  1. GERD-Health Related Quality of Life Questionnaire (GERD_HRQL)

    Time frame: baseline; 6,12,24 and 60 months

    Change in score for questionnaire related to quality of life with GERD

  2. RESQ-7 questionnaire

    Time frame: baseline; 6,12,24 & 60 months

    Change in score for questionnaire related to symptoms of GERD

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: TIF

Important dates

Study start
2020
Primary completion
2040
Study completion
2040
First posted
Mar 12, 2020
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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