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

NCT05778851 | Completed Results FDA Device

• 1 other identifier: ASBE
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral

  The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases.

  1 month

Secondary Outcomes (1)

• The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases

  1 month

Study Arms (2)

Control

NO INTERVENTION

Virtual patient cases with GERD and similar BE risk factors as the cases in intervention but without an EsoGuard result and in a different order.

Intervention

ACTIVE COMPARATOR

Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm with an EsoGuard result.

Device: EsoGuard result

Interventions

EsoGuard result DEVICE

Education slide-set EsoGuard and patient cases including EsoGuard result

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Have between 1 to 40 years of post-residency clinical experience within their field of practice;
• 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%.

You may not qualify if:

• None

Sponsors & Collaborators

• Lucid Diagnostics, Inc.: lead
• Medex15: collaborator

Study Sites (1)

Lucid Diagnostics

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Victoria T. Lee, MD CMO, SVM Clinical Affairs
• Organization: PAVmed Inc., Lucid Diagnostics Inc.

VTL@PAVmed.com

425.218.6535

Study Officials

• Victoria T Lee, MD

  Lucid Diagnostics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 21, 2023
• Study Start: April 12, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 19, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-03

Locations

US (1)