CompletedNot Applicable

CLUE: CLinical Utility Study of EsoGuard

United States566 participantsStarted 2023-02-23

Plain-language 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.

Who can participate

Age range12 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Clinical Utility

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT06030180

SponsorLucid Diagnostics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-13

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