Lucid Registry Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gisella Lopez

Role: STUDY_DIRECTOR

Lucid Diagnostics

Locations

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LUCID DX

Lake Forest, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alexa Rueda

Role: CONTACT

Phone: 9157405766

Email: [email protected]

Karyms Luna Miller