N/A
N=90
Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population
Barrett Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT05778851 ↗Enrolled (actual)
90
Serious AEs
—
Results posted
Oct 2025
Primary outcome: Primary: The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral — 382; 211 Cases
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EsoGuard result (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Lucid Diagnostics, Inc.
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral |
382; 211 | — |
| SECONDARY The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases |
53; 78 | — |
Summary
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.
The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).
After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
Eligibility Criteria
Inclusion Criteria
- Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons);
- Have between 1 to 40 years of post-residency clinical experience within their field of practice;
- Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05778851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.