CLUE: CLinical Utility Study of EsoGuard

Launched by LUCID DIAGNOSTICS, INC. · Sep 6, 2023

Keywords

ClinConnect Summary

The CLUE trial is studying how a test called EsoGuard, which checks for changes in the esophagus, affects doctors' decisions about whether to refer patients for a procedure called endoscopy. This trial looks at real-world data from patients who have already undergone another test called EsoCheck. It aims to understand if positive EsoGuard results lead to more patients getting the recommended endoscopies, which are important for detecting conditions like Barrett Esophagus and esophageal cancer early.

To participate in the trial, you need to be someone who is already being screened for Barrett Esophagus according to specific guidelines. This means you should have been identified by your doctor as needing this type of screening. Participants will engage in follow-up assessments after receiving their EsoGuard results to see how these results impact their healthcare decisions. The trial is currently recruiting individuals aged 43 to 361 years, and it’s open to everyone regardless of gender. If you meet the criteria and are willing to share your experiences, this trial could contribute to understanding the benefits of the EsoGuard test in managing esophageal health.

Gender

ALL

Eligibility criteria

• 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