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Barrett Esophagus
+3

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

Sponsored by Lucid Diagnostics, Inc.

About this trial

Last updated 2 years ago

Study ID

PR-0139 / EG-CL-101

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
50+ Years
Male
Male

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Men aged 50 years old and older

2. ≥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

3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure

4. One or more of the following risk factors:

1. Caucasian race
2. Current or past history of cigarette smoking
3. BMI of at least 30 kg/m2
4. First-degree relative with BE or EAC -
No

Exclusion Criteria

1. History of prior EGD procedure

2. Inability to provide written informed consent

3. On anti-coagulant drug(s) that cannot be temporarily discontinued

4. Known history of esophageal varices or esophageal stricture

5. 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

6. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills

7. Oropharyngeal tumor

8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure

9. History of myocardial infarction or cerebrovascular accident within past 6 months

10. History of esophageal motility disorder

11. Currently implanted Linx device

Locations

Location

Status