Transoral Incisionless Fundoplication Database Repository (TIF) (TIF)

• ClinicalTrials.gov Identifier: NCT04306380
• Recruitment Status: Enrolling by invitation
• First Posted: March 12, 2020
• Last Update Posted: January 12, 2024
• Sponsor: Indiana University
• Information provided by (Responsible Party): John DeWitt, Indiana University

Tracking Information

• First Submitted Date: March 8, 2020
• First Posted Date: March 12, 2020
• Last Update Posted Date: January 12, 2024
• Actual Study Start Date: May 20, 2020
• Estimated Primary Completion Date: December 31, 2040 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2020)

• 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
• RESQ-7 questionnaire [ Time Frame: baseline; 6,12,24 & 60 months ]
  Change in score for questionnaire related to symptoms of GERD

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transoral Incisionless Fundoplication Database Repository (TIF)
• Official Title: Transoral Incisionless Fundoplication Database Repository (TIF)
• Brief 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.
• 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Able to give written informed consent and having a TIF procedure for GERD at Indiana University, IU Health university Hospital. Those participants between the age of 13-18 will sign an assent while the parent or guardian will sign the informed consent.
• Condition: Gastroesophageal Reflux Disease

Intervention

Other: no intervention, database study

data collection from EMR for database

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: March 10, 2020): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2040
• Estimated Primary Completion Date: December 31, 2040 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• under 13 years of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04306380
• Other Study ID Numbers: 2001738876
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: John DeWitt, Indiana University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indiana University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Indiana University
• Verification Date: January 2024