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NCT03853772 Clinical Trial

The Johns Hopkins Heartburn Center Registry

Gastroesophageal Reflux Disease Clinical Trial

Official title:
The Johns Hopkins Heartburn Center Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03853772
Other study ID # IRB00201157
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 27, 2019
Est. completion date December 2025

Study information
Verified date May 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 2000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Fox Valley Surgical Associates Appleton Wisconsin
United States Johns Hopkins Hospital Baltimore Maryland
United States The Matagorda Regional Medical Group Bay City Texas
United States Geisinger Danville Pennsylvania
United States UT Health Houston Texas
United States Weill Cornell New York New York
United States UCI-Irvine Orange California
United States UNRMed-University of Nevada, Reno Reno Nevada
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University EndoGastric Solutions

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Demographic and clinical data obtained via chart review and questionnaires 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
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