Gastroesophageal Reflux DiseaseNCT03853772
The Johns Hopkins Heartburn Center Registry
An observational study of Gastroesophageal Reflux Disease and Barrett Esophagus, run by Johns Hopkins University at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Barrett Esophagus, Laryngopharyngeal Reflux
- How many people
- 2,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Apr 2019to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred by physicians having diagnostic evaluation or treatment for GERD.
Who may be able to join
- Referred GERD patients willing to participate in long term follow-up (5 years)
Who cannot join
- Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Fox Valley Surgical Associates
Appleton, Wisconsin, 54911
Johns Hopkins Hospital
Baltimore, Maryland, 21287
The Matagorda Regional Medical Group
Bay City, Texas, 77414
Geisinger
Danville, Pennsylvania, 17822
UT Health
Houston, Texas, 77030
Weill Cornell
New York, New York, 10065
UCI-Irvine
Orange, California, 92868
UNRMed-University of Nevada, Reno
Reno, Nevada, 89557
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus, Laryngopharyngeal Reflux, Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start27 Apr 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- EndoGastric Solutions
- Responsible party
- Sponsor
- Investigators
- Marcia Canto, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853772
- Sponsor's protocol ID
- IRB00201157
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2019
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.
Publications
Kolb JM, Canto MI, Parker B, Murray M, Brewer Gutierrez OI, Sharaiha RZ, Abu-Dayyeh BK, Janu P, Chang KJ, Nguyen NT. Short-Term Outcomes of Laparoscopic Hiatal Hernia Repair with Consecutive Transoral Incisionless Fundoplication: A Prospective Multicenter Cohort Study. J Am Coll Surg. 2026 Nov 1;243(5):1220-1229. doi: 10.1097/XCS.0000000000002059. Epub 2026 Jun 3.
PubMed 42233490
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Johns Hopkins Heartburn Center Registry
- ClinicalTrials.gov ID
- NCT03853772
- Acronym / sponsor ID
- IRB00201157
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- EndoGastric Solutions
- Study start
- 27 Apr 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred by physicians having diagnostic evaluation or treatment for GERD.
Key inclusion criteria (1 listed)
- Referred GERD patients willing to participate in long term follow-up (5 years)
Key exclusion criteria (1 listed)
- Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 42233490Kolb JM, Canto MI, Parker B, Murray M, Brewer Gutierrez OI, Sharaiha RZ, Abu-Dayyeh BK, Janu P, Chang KJ, Nguyen NT. Short-Term Outcomes of Laparoscopic Hiatal Hernia Repair with Consecutive Transoral Incisionless Fundoplication: A Prospective Multicenter Cohort Study. J Am Coll Surg. 2026 Nov 1;243(5):1220-1229. doi: 10.1097/XCS.0000000000002059. Epub 2026 Jun 3.
- Individual participant dataSharing planned: Yes. Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcia Canto, MD principal investigator
Johns Hopkins University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Barrett Esophagus, run by Johns Hopkins University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and clinical data obtained via chart review and questionnaires (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.