CLUE: CLinical Utility Study of EsoGuard

NCT06030180 | Completed FDA Device

• 1 other identifier: PR-0410
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 8

Brief 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

Barrett Esophagus; Barretts Esophagus With Dysplasia; Esophagus Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Clinical Utility

  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. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Patient Compliance

  Through study completion, an average of 1 year

Study Arms (1)

Single Arm Study

OTHER

Device: EsoGuard

Interventions

EsoGuard DEVICE

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)

Also known as: EsoGuard test on cells collected using EsoCheck

Single Arm Study

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Lucid Diagnostics, Inc.: lead

Study Sites (8)

Arkansas Heartburn Treatment Center

Heber Springs, Arkansas, 72543, United States

Location

Arvada West Family Medicine,

Arvada, Colorado, 80004, United States

Location

Colorado Primary Healthcare

Littleton, Colorado, 80120, United States

Location

Savii Health

Savannah, Georgia, 31406, United States

Location

James E Race

Dallas, Texas, 75224, United States

Location

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

Location

Gastroenterology Partners of North Houston, PLLC

Shenandoah, Texas, 77384, United States

Location

Premier Family Medical

Lindon, Utah, 84042, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gisella Lopez

  Lucid Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 8, 2023
• Study Start: February 23, 2023
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)