Status:
COMPLETED
CLUE: CLinical Utility Study of EsoGuard
Lead Sponsor:
Lucid Diagnostics, Inc.
Conditions:
Barrett Esophagus
Barretts Esophagus With Dysplasia
Eligibility:
All Genders
12-99 years
Phase:
NA
Brief Summary
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endosco...
Eligibility Criteria
Inclusion
- Individuals in whom the clinical decision has been made to screen for BE using EC/EG
- Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.
Exclusion
- Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
- Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
- Inability to provide written informed consent or participate in the required follow up
Key Trial Info
Start Date :
February 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT06030180
Start Date
February 23 2023
End Date
December 13 2024
Last Update
June 27 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Arkansas Heartburn Treatment Center
Heber Springs, Arkansas, United States, 72543
2
Arvada West Family Medicine,
Arvada, Colorado, United States, 80004
3
Colorado Primary Healthcare
Littleton, Colorado, United States, 80120
4
Savii Health
Savannah, Georgia, United States, 31406