CLUE: CLinical Utility Study of EsoGuard
Completed · Not applicable
Conditions studied: Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06030180
- Run by
- Lucid Diagnostics, Inc.
- People needed
- 566
- Starts
- 2023-02-23
- Expected to finish
- 2024-12-13
- Last updated by the study team
- 2025-06-27
Who can join
Age: 12 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Arkansas Heartburn Treatment Center — Heber Springs, Arkansas, United States
- Arvada West Family Medicine, — Arvada, Colorado, United States
- Colorado Primary Healthcare — Littleton, Colorado, United States
- Savii Health — Savannah, Georgia, United States
- James E Race — Dallas, Texas, United States
- Texas Digestive Specialists — Harlingen, Texas, United States
- Gastroenterology Partners of North Houston, PLLC — Shenandoah, Texas, United States
- Premier Family Medical — Lindon, Utah, United States
Full record on ClinicalTrials.gov
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