Trials / Completed
CompletedNCT06030180
CLUE: CLinical Utility Study of EsoGuard
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 566 (actual)
- Sponsor
- Lucid Diagnostics, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 99 Years
- Healthy volunteers
- Not accepted
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 endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EsoGuard | EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1) |
Timeline
- Start date
- 2023-02-23
- Primary completion
- 2024-12-13
- Completion
- 2024-12-13
- First posted
- 2023-09-08
- Last updated
- 2025-06-27
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06030180. Inclusion in this directory is not an endorsement.