We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Johns Hopkins Heartburn Center Registry

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: NCT03853772
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2019
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
EndoGastric Solutions
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease
Gastroesophageal Reflux Disease Barrett Esophagus Laryngopharyngeal Reflux Esophagitis

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Johns Hopkins Heartburn Center Registry
Actual Study Start Date : April 27, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn




Primary Outcome Measures :
  1. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred by physicians having diagnostic evaluation or treatment for GERD.
Criteria

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

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): NCT03853772


Locations
Layout table for location information
United States, California
UCI-Irvine
Orange, California, United States, 92868
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nevada
UNRMed-University of Nevada, Reno
Reno, Nevada, United States, 89557
United States, New York
Weill Cornell
New York, New York, United States, 10065
United States, Pennsylvania
Geisinger
Danville, Pennsylvania, United States, 17822
United States, Texas
The Matagorda Regional Medical Group
Bay City, Texas, United States, 77414
UT Health
Houston, Texas, United States, 77030
United States, Wisconsin
Fox Valley Surgical Associates
Appleton, Wisconsin, United States, 54911
Sponsors and Collaborators
Johns Hopkins University
EndoGastric Solutions
Investigators
Layout table for investigator information
Principal Investigator: Marcia Canto, MD Johns Hopkins University
Additional Information:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03853772    
Other Study ID Numbers: IRB00201157
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: minimum 6 years
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Gastroesophageal Reflux
Esophagitis
Laryngopharyngeal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Precancerous Conditions
Neoplasms
Signs and Symptoms, Digestive
Laryngeal Diseases
Respiratory Tract Diseases