The Johns Hopkins Heartburn Center Registry

November 16, 2023 updated by: Johns Hopkins University
A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

This registry is a prospective, multicenter registry of patients undergoing diagnostic evaluation and/or treatment of gastroesophageal reflux disease and associated diseases and complications.

Patients who are eligible will have disease and therapy-specific data collected throughout treatment and long-term (5-year) follow-up.

Electronic data capture via REDCap will be utilized for all sites.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UCI-Irvine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nevada
      • Reno, Nevada, United States, 89557
        • UNRMed-University of Nevada, Reno
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger
    • Texas
      • Bay City, Texas, United States, 77414
        • The Matagorda Regional Medical Group
      • Houston, Texas, United States, 77030
        • UT Health
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Fox Valley Surgical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients referred by physicians having diagnostic evaluation or treatment for GERD.

Description

Inclusion Criteria:

  • Referred GERD patients willing to participate in long term follow-up (5 years)

Exclusion Criteria:

  • Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic and clinical data obtained via chart review and questionnaires
Time Frame: 5 years
Establish a registry with collected data related to patients undergoing diagnostic evaluation and treatment of GERD and its associated diseases in multiple academic and community settings.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

EndoGastric Solutions

Investigators

  • Principal Investigator: Marcia Canto, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00201157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.

IPD Sharing Time Frame

minimum 6 years

IPD Sharing Access Criteria

Project submission to PI and or Heartburn Registry management team then if project accepted, security clearance and enrollment in REDCap and tutorial completions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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