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Transoral Incisionless Fundoplication Database Repository (TIF) (TIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04306380
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2020
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
John DeWitt, Indiana University

Study Description
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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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Other: no intervention, database study

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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transoral Incisionless Fundoplication Database Repository (TIF)
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : December 31, 2040
Estimated Study Completion Date : December 31, 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
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Intervention Details:
  • Other: no intervention, database study
    data collection from EMR for database

Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • under 13 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306380


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202-5121
Sponsors and Collaborators
Indiana University
More Information
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Responsible Party: John DeWitt, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04306380    
Other Study ID Numbers: 2001738876
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases