Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE

Completed · Not applicable

Conditions studied: Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia

In brief

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 without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.

Key facts

Study ID

NCT04293458

Run by

Lucid Diagnostics, Inc.

People needed

145

Starts

2020-02-28

Expected to finish

2022-08-22

Last updated by the study team

2023-01-25

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lucid Investigative Site — Orange, California, United States
• Lucid Investigative Site — Englewood, Colorado, United States
• Lucid Investigative Site — Naples, Florida, United States
• Lucid Investigative Site — Palm Harbor, Florida, United States
• Lucid Investigative Site — Macon, Georgia, United States
• Lucid Investigative Site — Idaho Falls, Idaho, United States
• Lucid Investigative Site — Rockford, Illinois, United States
• Lucid Investigative Site — New Orleans, Louisiana, United States
• Lucid Investigative Site — Shreveport, Louisiana, United States
• Lucid Investigative Site — Wyoming, Michigan, United States
• Lucid Investigative Site — Flowood, Mississippi, United States
• Lucid Investigative Site — Omaha, Nebraska, United States
• Lucid Investigative Site — New York, New York, United States
• Lucid Investigative Site — Rochester, New York, United States
• Lucid Investigative Site — Chapel Hill, North Carolina, United States
• Lucid Investigative Site — Oklahoma City, Oklahoma, United States
• Lucid Investigative Site — Philadelphia, Pennsylvania, United States
• Lucid Investigative Site — Greenville, South Carolina, United States
• Lucid Investigative Site — Knoxville, Tennessee, United States
• Lucid Investigative Site — Nashville, Tennessee, United States
• Lucid Investigative Site — Houston, Texas, United States
• Lucid Investigative Site — Salt Lake City, Utah, United States
• Lucid Investigative Site — Richmond, Virginia, United States
• Lucid Investigative Site — Richmond, Virginia, United States
• Lucid Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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