Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia, Esophageal Adenocarcinoma
Conditions
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.
Interventions
DEVICEEsoCheck
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.
Sponsors
Lucid Diagnostics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAlexa Rueda
Backup ContactKaryms Luna Miller
Outcome results
None listed