GERDGERDNCT02479438
Gastroesophageal Reflux Disease Prospective Registry
An observational study of GERD, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Diagnosed with GERD
- How many people
- 744 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with diagnosis of GERD or a similar disease of the stomach, esophagus or digestive tract.
Who may be able to join
- Any patient undergoing anti-reflux surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Research University Medical Center
Dallas, Texas, 75246
About this study
The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.
Read the detailed description
All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.
- Conditions
- GERD
- Being tested
- Diagnosed with GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosed with GERDOther
Recording of patient outcomes
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with GERD | Collect data on GERD patients Receives: Other: Diagnosed with GERD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative patient reported sign and symptoms
Patient reported signs and symptoms as reported in Reflux scale and GERD questionnaire.
Measured: Up to 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2024
- Study completionSep 2024
Why it stopped: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 744 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Leeds, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479438
- Sponsor's protocol ID
- 014-008
- Acronym
- GERD
- Status last verified
- May 2025
- First submitted
- 7 May 2015
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophageal Reflux Disease Prospective Registry
- ClinicalTrials.gov ID
- NCT02479438
- Acronym / sponsor ID
- GERD / 014-008
- Conditions
- GERD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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.
The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.
Detailed description
All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with GERD | – | Other: Diagnosed with GERDCollect data on GERD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of GERD or a similar disease of the stomach, esophagus or digestive tract.
Key inclusion criteria (1 listed)
- Any patient undergoing anti-reflux surgery
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosed with GERDRecording of patient outcomes | Other | Diagnosed with GERD |
Primary outcome
Postoperative patient reported sign and symptoms
Time frame: Up to 10 years after surgery
Patient reported signs and symptoms as reported in Reflux scale and GERD questionnaire.
Results and safety
The study was stopped early (reason given: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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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. This study is not recruiting at the moment.
Steven Leeds, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Baylor Research Institute at 1 site 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: stopped early, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.). Results are not available in the source record.
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?
Postoperative patient reported sign and symptoms (time frame: Up to 10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.