CLUE: CLinical Utility Study of EsoGuard

Barrett Esophagus Clinical Trial

— PR-0410  

Official title:

CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030180
• Other study ID #: PR-0410
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: September 2023
• Source: PAVmed Inc.
• Contact: Alexa Rueda
• Phone: 9157405766
• Email: axr[@]pavmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With Dysplasia
• Esophagus Adenocarcinoma

Intervention

Device:
• EsoGuard
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)

Locations

Country	Name	City	State
United States	Arvada West Family Medicine,	Arvada	Colorado
United States	James E Race	Dallas	Texas
United States	Texas Digestive Specialists	Harlingen	Texas
United States	Arkansas Heartburn Treatment Center	Heber Springs	Arkansas
United States	Premier Family Medical	Lindon	Utah
United States	Colorado Primary Healthcare	Littleton	Colorado
United States	Savii Health	Savannah	Georgia
United States	Gastroenterology Partners of North Houston, PLLC	Shenandoah	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lucid Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Compliance	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.	Through study completion, an average of 1 year