Lucid Registry Study

Barrett Esophagus Clinical Trial

— Lucid Registry  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965999
• Other study ID #: LUD-PR-0421
• Status: Recruiting
• Start date: April 11, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: PAVmed Inc.
• Contact: Alexa Rueda
• Phone: 9157405766
• Email: axr[@]pavmed.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett's Esophagus Without Dysplasia
• Barretts Esophagus With Dysplasia
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	LUCID DX	Lake Forest	California

Sponsors (1)

Lead Sponsor	Collaborator
Lucid Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of subjects with a positive EsoGuard test		Through study completion, an average of 1 year
Secondary	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