CLUE: CLinical Utility Study of EsoGuard (PR-0410)

Lucid Diagnostics

Status: Enrolling

Conditions: Barretts Esophagus With Dysplasia; Esophagus Adenocarcinoma; Barrett Esophagus

Treatments: Device: EsoGuard

Study type: Interventional

Funder types: Industry

Identifiers

NCT06030180

PR-0410

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG
2. 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

1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
3. Inability to provide written informed consent or participate in the required follow up

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Single Arm Study

Other group

Treatment:

Device: EsoGuard