Status:
COMPLETED
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
Lead Sponsor:
Lucid Diagnostics, Inc.
Conditions:
Barrett Esophagus
Esophageal Adenocarcinoma
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and w...
Detailed Description
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell...
Eligibility Criteria
Inclusion
- Men aged 50 years old and older
- ≥5 years either of
- GERD symptoms,
- GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
- any combination of treated and untreated periods, as long the cumulative total is at least 5 years
- No solid foods eaten for at least 2 hours prior to EsoCheck procedure
- One or more of the following risk factors:
- Caucasian race
- Current or past history of cigarette smoking
- BMI of at least 30 kg/m2
- First-degree relative with BE or EAC
- \-
Exclusion
- History of prior EGD procedure
- Inability to provide written informed consent
- On anti-coagulant drug(s) that cannot be temporarily discontinued
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
- History of myocardial infarction or cerebrovascular accident within past 6 months
- History of esophageal motility disorder
- Currently implanted Linx device
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04293458
Start Date
February 28 2020
End Date
August 22 2022
Last Update
January 25 2023
Active Locations (27)
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1
Lucid Investigative Site
Orange, California, United States, 92868
2
Lucid Investigative Site
Englewood, Colorado, United States, 80113
3
Lucid Investigative Site
Naples, Florida, United States, 34102
4
Lucid Investigative Site
Palm Harbor, Florida, United States, 34684