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Trial Title:
Lucid Registry Study
NCT ID:
NCT05965999
Condition:
Barrett Esophagus
Esophageal Adenocarcinoma
Barretts Esophagus With Dysplasia
Barrett's Esophagus Without Dysplasia
Conditions: Official terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
EsoCheck
Description:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
LUCID DX
Address:
City:
Lake Forest
Zip:
92630
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tiffany To
Start date:
April 11, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Lucid Diagnostics, Inc.
Agency class:
Industry
Source:
PAVmed Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965999
