Lucid Registry Study

• Sponsor: Lucid Diagnostics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05965999
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 13.7
• Patients Per Site Per Month: 36.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus; Esophageal Adenocarcinoma; Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia	Device: EsoCheck

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter, Prospective, Open-Label Registry Study of the Utilization of EsoGuard, on Samples Collected Using EsoCheck, in an At-Risk Population Undergoing Standard of Care Screening for, and Management of, Previously Undiagnosed Barrett's Esophagus and/or Esophageal Adenocarcinoma
• Actual Study Start Date: Apr 11, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. The number of subjects with a positive EsoGuard test [Through study completion, an average of 1 year]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LUCID DX	Lake Forest	California	United States	92630

Sponsors and Collaborators

• Lucid Diagnostics, Inc.

Investigators

• Study Director: Gisella Lopez, Lucid Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lucid Diagnostics, Inc.
• ClinicalTrials.gov Identifier: NCT05965999
• Other Study ID Numbers: LUD-PR-0421
• First Posted: Jul 28, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Adenocarcinoma; Barrett Esophagus; Esophageal Neoplasms

Study Results

No Results Posted as of Jul 28, 2023