Recruiting

Observational Study

Sponsor:

Lucid Diagnostics, Inc.

Code:

NCT05965999

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Barretts Esophagus With Dysplasia

Barrett's Esophagus Without Dysplasia

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

EsoCheck

Study Details

Brief summary:

This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for EsoGuard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (EDC) system, pertaining to subject demographics, pertinent medical history, and risk factors for BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient tolerance, (2) EsoGuard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken), as well as (4) additional clinical management and/or a therapeutic procedure(s) performed. The time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the EsoGuard result being available. It is expected typically to be approximately 4 months given the systemic delays in scheduling and performing upper endoscopies and obtaining biopsy results. There is no a priori limit on the timeline for obtaining these data, but it is . anticipated that all data collection will be completed within 8 months of the availability of EsoGuard results.

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Barretts Esophagus With Dysplasia

Barrett's Esophagus Without Dysplasia

Study ID

NCT05965999

Start date

Apr 11, 2023

Status verified date

Jul, 2023

Completion date

Jun 1, 2024

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and Females who have provided informed consent for prospective registry participation
2. Subject in whom the clinical decision has been made to screen for BE/EAC using EsoGuard testing on samples collected with EsoCheck

Exclusion Criteria:

1. Inability to provide written informed consent
2. Subjects who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

EsoCheck

EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older.

Primary outcome measure

  • Agreement between positive EsoGuard test results and upper endoscopy diagnosis (i.e., subjects with BE/EAC newly diagnosed by upper endoscopy) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Karyms Luna Miller

klm@pavmed.com

Locations

LUCID DX

Recruiting

Lake Forest, California, United States, 92630

More Information

Sponsor

Lucid Diagnostics, Inc.

Last update posted

Jul 28, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lucid Diagnostics, Inc. on 2023-07-28.