Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population

Not Applicable

Completed

• Conditions: Barrett Esophagus
• Interventions: Device: EsoGuard result

• Registration Number: NCT05778851
• Lead Sponsor: Lucid Diagnostics, Inc.

Brief Summary

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).

After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

Detailed Description

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

Around 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-21
• Study Start: 2023-04-12
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons);
2. Have between 1 to 40 years of post-residency clinical experience within their field of practice;
3. Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
B2 Intervention	EsoGuard result	6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm B1 with an EsoGuard result. 5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
A2 Intervention	EsoGuard result	6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm A1 with an EsoGuard result. 5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
C2 Intervention	EsoGuard result	6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm C1 with an EsoGuard result. 5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).

Primary Outcome Measures

Name	Time	Method
The impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral	1 month	The change in the percentage/rate of virtual patient cases who will be referred for endoscopy in the intervention round compared to the control round.; The proportion of patient cases in round 2 for which the provider indicated that the EsoGuard result influenced his/her decision to refer the patient for upper endoscopy divided by all patient cases in round 2.

Secondary Outcome Measures

Name	Time	Method
The impact of EsoCheck/EsoGuard on health care provider's patient risk assessment for BE	1 month	The change in the provider's virtual patient risk assessment for BE in the intervention round compared to the control round.

Trial Locations

Locations (1)

Lucid Diagnostics; 🇺🇸 New York, New York, United States