Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC

Description

The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

Conditions

Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia

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Study Overview

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Study Details

Study overview

The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

A Multicenter Case-Control Study of the Efficacy of EsoGuard on Samples Collected Using EsoCheck, Versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett's Esophagus With and Without Dysplasia, and for Esophageal Adenocarcinoma

Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC

Condition
Barrett Esophagus
Intervention / Treatment

-

Contacts and Locations

Birmingham

Lucid Investigative Site, Birmingham, Alabama, United States, 35294

Orange

Lucid Investigative Site, Orange, California, United States, 92868

Aurora

Lucid Investigative Site, Aurora, Colorado, United States, 80045

Englewood

Lucid Investigative Site, Englewood, Colorado, United States, 80113

Washington

Lucid Investigative Site, Washington, District of Columbia, United States, 20007

Jacksonville

Lucid Investigative Site, Jacksonville, Florida, United States, 32256

Chicago

Lucid Investigative Site, Chicago, Illinois, United States, 60611

Shreveport

Lucid Investigative Site, Shreveport, Louisiana, United States, 71105

Baltimore

Lucid Investigative Site, Baltimore, Maryland, United States, 21287

Boston

Lucid Investigative Site, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Men aged 50 years and above
  • 2. ≥5 years either of
  • * Gastroesophageal Reflux Disease (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:
  • * Caucasian race
  • * Current or past history of cigarette smoking
  • * Body mass index (BMI) of at least 30 kg/m2
  • * First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC)
  • 1. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
  • 2. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
  • 3. Indicated for surveillance EGD or for therapeutic EGD
  • 4. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD
  • 1. Inability to provide written informed consent
  • 2. On anti-coagulant drug(s) that cannot be temporarily discontinued
  • 3. Known history of esophageal varices or esophageal stricture
  • 4. 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
  • 5. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  • 6. Oropharyngeal tumor
  • 7. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  • 8. History of myocardial infarction or cerebrovascular accident within past 6 months
  • 9. Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
  • 10. Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
  • 11. Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC
  • 12. History of esophageal motility disorder
  • 13. Currently implanted Linx device

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Lucid Diagnostics, Inc.,

Michelle McDermott, STUDY_DIRECTOR, Lucid Diagnostics, Inc.

Study Record Dates

2023-12