An observational study in Barrett Esophagus, Esophageal Adenocarcinoma and Barretts Esophagus With Dysplasia, sponsored by Lucid Diagnostics, Inc.. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Lucid Diagnostics, Inc. · Observational
Among 209 studies in Barrett Esophagus with a site in United States — 38 open to participants now, 48 under way, none of them phase 3. Barrett Esophagus · United States.
Among the 209 studies in Barrett Esophagus with a site in United States, this one is the 3rd largest by planned enrollment of the 86 observational ones that give a count, is one of 9 that started in 2023, is one of 87 observational ones, reaches primary completion later than 23 of the 47 other live ones, and was the 190th registered.
312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.
This study's planned enrollment of 8,000 is above the median of 144 across 118 observational studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →38 of the 209 studies in Barrett Esophagus with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 44 Barrett Esophagus studies recruiting now, 31 (70%) set no upper age limit and 2 (5%) stop at 75 or younger; 4 take children under 18; 10 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →209 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 9 started in 2023.
Median enrollment 58 across the 122 interventional studies, 123 across the 86 observational. Of the 141 that completed or were terminated, 45 (32%) have results posted.
37 of 209 have an industry lead sponsor. The 10 most frequent:
Lucid Diagnostics, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Lucid Diagnostics, Inc. has 5 studies filed under Barrett Esophagus — fewer than ten, so there is no comparison to draw.
14 of the studies in Barrett Esophagus with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT00590239Midwest Biomedical Research FoundationBarrett's Esophagus Related Neoplasia (BERN) Project | 2026-11-01 |
| NCT03316053The Guthrie ClinicCell Marker Predictors in Barrett's Esophagus | 2026-12-01 |
| NCT02634645University of Colorado, DenverTREAT-BE Study (Treatment with Resection and Endoscopic Ablation Techniques for Barrett's Esophagus) | 2027-01 |
| NCT05468008AdventHealthEndoscopic Submucosal Dissection (ESD) | 2027-02 |
Among the 209 studies in Barrett Esophagus with a site in United States, from their registry updates:
This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for EsoGuard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (EDC) system, pertaining to subject demographics, pertinent medical history, and risk factors for BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient tolerance, (2) EsoGuard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken.
For subjects endoscopically confirmed with intestinal metaplasia, dysplasia, or cancer, the registry will collect additional clinical management and/or a therapeutic procedure(s) performed and other mid- to long-term outcomes.
For subjects who are negative for BE/EAC via EsoGuard or negative for BE/EAC via EGD will be offered the option of longer-term follow-up in the form of intermittent wellness checks.
The time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the EsoGuard result being available. Subject participation duration is dependent on EsoGuard results, physician referral, EGD results (if referred) and participation in long-term follow-up. If EG results are negative and subject is not referred for an EGD, participation could last 1 month. If a subject is confirmed with BE/EAC, participation may continue beyond this minimum for an indefinite period, with no predetermined maximum duration.
Subjects who have recently undergone or are scheduled to undergo EsoCheck administration (as prescribed by a licensed healthcare provider) will be invited to participate in the optional EsoGuard Registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older.
EsoGuard® is a DNA assay which examines for the presence of cytosine methylation at 31 different genomic locations on the vimentin (VIM) and Cyclin-A1 (CCNA1) genes. Using EsoCheck and EsoGuard in combination may offer an accurate, lower cost, non-invasive, approach to screen for Barrett's Esophagus (BE) with and without dysplasia, and for esophageal adenocarcinoma (EAC).
Subsequent Clinical Management Following EsoGuard Testing
Proportion of subjects who undergo a clinically relevant management action following receipt of an EsoGuard result, including referral for esophagogastroduodenoscopy (EGD), surveillance, therapeutic intervention, or other physician-directed management. Clinical management decisions are collected as part of routine clinical care.
Time frame: Up to 12 months following EsoGuard testing
Endoscopic Confirmation of Barrett's Esophagus and/or Esophageal Neoplasia
Proportion of subjects with a completed EGD and pathology assessment confirming Barrett's esophagus (BE), dysplasia, esophageal adenocarcinoma (EAC), or other relevant esophageal findings following EsoGuard testing.
Time frame: Up to 12 months following EsoGuard testing
Disease Stage at Endoscopic Diagnosis
Histologic and/or clinical stage of Barrett's esophagus, dysplasia, or esophageal neoplasia identified during clinically indicated endoscopic evaluation following EsoGuard testing.
Time frame: Up to 12 months following EsoGuard testing
Therapeutic Interventions Following EsoGuard Testing
Proportion of subjects who undergo therapeutic intervention for BE, dysplasia, or EAC, including endoscopic eradication therapy, surgical intervention, pharmacologic treatment, or other standard-of-care management.
Time frame: Up to 12 months following EsoGuard testing
Surveillance Utilization Following EsoGuard Testing
Proportion of subjects who undergo follow-up surveillance procedures or monitoring for BE/EAC according to routine clinical practice.
Time frame: Up to 24 months following EsoGuard testing
Incident Detection of Barrett's Esophagus or Esophageal Adenocarcinoma
Number and proportion of subjects initially considered negative for BE/EAC who subsequently receive a diagnosis of BE, dysplasia, or EAC during follow-up.
Time frame: Up to 24 months following EsoGuard testing
Disease Progression or Resolution
Among subjects with identified esophageal disease, assessment of disease progression, stability, or resolution based on available endoscopic, histologic, and clinical follow-up data.
Time frame: Up to 24 months following EsoGuard testing
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2027, 56 months after the start.
Of 40 observational studies under Barrett Esophagus, half reached primary completion within 252 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 252. This study's planned 56 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Lucid Diagnostics, Inc.