Lucid Registry Study

NCT05965999 | Unknown FDA Device

• 1 other identifier: LUD-PR-0421
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Agreement between positive EsoGuard test results and upper endoscopy diagnosis (i.e., subjects with BE/EAC newly diagnosed by upper endoscopy)

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• The number of subjects with a positive EsoGuard test

  Through study completion, an average of 1 year

• Agreement between negative EsoGuard test results and upper endoscopy diagnosis (i.e., subjects determined not to have BE/EAC on upper endoscopy)

  Through study completion, an average of 1 year

Interventions

EsoCheck DEVICE

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.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have recently undergone or are scheduled to undergo EsoCheck administration (as prescribed by a licensed healthcare provider) will be invited to participate in the optional EsoGuard Registry.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lucid Diagnostics, Inc.: lead

Study Sites (1)

LUCID DX

Lake Forest, California, 92630, United States

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

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

Study Officials

• Gisella Lopez

  Lucid Diagnostics

  STUDY DIRECTOR

Central Study Contacts

Alexa Rueda

CONTACT

9157405766; axr@pavmed.com

Karyms Luna Miller

CONTACT

klm@pavmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: July 28, 2023
• Study Start: April 11, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)