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NCT04306380 Clinical Trial

Transoral Incisionless Fundoplication Database Repository (TIF)

Gastroesophageal Reflux Disease Clinical Trial

— TIF  

Official title:
Transoral Incisionless Fundoplication Database Repository (TIF)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04306380
Other study ID # 2001738876
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 20, 2020
Est. completion date December 31, 2040

Study information
Verified date January 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date December 31, 2040
Est. primary completion date December 31, 2040
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility Inclusion Criteria: - Having a TIF procedure completed at Indiana University Health, University Hospital Exclusion Criteria: - under 13 years of age

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Indiana University Hospital Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary GERD-Health Related Quality of Life Questionnaire (GERD_HRQL) Change in score for questionnaire related to quality of life with GERD baseline; 6,12,24 and 60 months
Primary RESQ-7 questionnaire Change in score for questionnaire related to symptoms of GERD baseline; 6,12,24 & 60 months
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