NCT04306380

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
178mo left

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
May 2020Dec 2040

First Submitted

Initial submission to the registry

March 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
20.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

February 24, 2026

Status Verified

January 1, 2026

Enrollment Period

20.6 years

First QC Date

March 8, 2020

Last Update Submit

February 22, 2026

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • RESQ-7 questionnaire

    Change in score for questionnaire related to symptoms of GERD

    baseline; 6,12,24 & 60 months

Interventions

no intervention, database studyOTHER

data collection from EMR for database

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • under 13 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 12, 2020

Study Start

May 20, 2020

Primary Completion (Estimated)

December 31, 2040

Study Completion (Estimated)

December 31, 2040

Last Updated

February 24, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)