CLUE: CLinical Utility Study of EsoGuard

Not Applicable

Recruiting

• Conditions: Esophagus Adenocarcinoma; Barrett Esophagus; Barretts Esophagus With Dysplasia
• Interventions: Device: EsoGuard

• Registration Number: NCT06030180
• Lead Sponsor: Lucid Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-23
• Study First Submitted: 2023-08-25
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	EsoGuard	-

Primary Outcome Measures

Name	Time	Method
Clinical Utility	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Patient Compliance	Through study completion, an average of 1 year	Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred.

Trial Locations

Locations (8)

Texas Digestive Specialists; 🇺🇸 Harlingen, Texas, United States

Colorado Primary Healthcare; 🇺🇸 Littleton, Colorado, United States

Arkansas Heartburn Treatment Center; 🇺🇸 Heber Springs, Arkansas, United States

Premier Family Medical; 🇺🇸 Lindon, Utah, United States

Arvada West Family Medicine,; 🇺🇸 Arvada, Colorado, United States

Savii Health; 🇺🇸 Savannah, Georgia, United States

James E Race; 🇺🇸 Dallas, Texas, United States

Gastroenterology Partners of North Houston, PLLC; 🇺🇸 Shenandoah, Texas, United States