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

NCT04295811 | Unknown FDA Device

• 1 other identifier: PR-0138 / EG-CL-102
• Study Type: interventional
• Target: 470
• Locations: 2 countries
• Sites: 38

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy

  The primary efficacy endpoint is the sensitivity of EsoGuard. The primary efficacy objectives of this study are to measure the sensitivities of EsoGuard-based diagnosis in 54 cases each of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and intramucosal adenocarcinoma (IMC) in order to assess EsoGuard's ability to detect disease across the entire continuum of disease progression.

  Per subject analysis through study completion which is up to approximately 5 weeks

Secondary Outcomes (1)

• Secondary Efficacy

  Per subject through study completion which is up to approximately 5 weeks

Other Outcomes (1)

• Safety outcome of EsoCheck Device (510k cleared, non-invasive, esophageal cell collection device) on all patients who undergo the device procedure.

  Per subject through study completion which is up to approximately 5 weeks

Study Arms (1)

EsoCheck and EsoGuard vs. EGD with or without biopsies

EXPERIMENTAL

All subjects will undergo both the EsoGuard lab assay run on distal esophageal cells collected with EsoCheck (non-invasive esophageal cell sample collection) device followed by Esophagogastroduodenoscopy (EGD) with or without biopsies

Device: EsoGuard (lab assay); Diagnostic Test: Esophagogastroduodenoscopy

Interventions

EsoGuard (lab assay) DEVICE

EsoGuard assay (LDT) will be used on cells collected using the EsoCheck (510K cleared esophageal cell collection device)

Also known as: EsoCheck (esophageal cell sample collection device)

EsoCheck and EsoGuard vs. EGD with or without biopsies

Esophagogastroduodenoscopy DIAGNOSTIC_TEST

Planned EGD to diagnose and/or treat disorders of esophagus, stomach, and small intestine. When abnormal tissues are noted, biopsies of the tissue are taken through the scope to diagnose tissue abnormalities.

Also known as: EGD

EsoCheck and EsoGuard vs. EGD with or without biopsies

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patients:
• Men aged 50 years and above
• ≥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
• No solid foods eaten for at least 2 hours prior to EsoCheck procedure
• 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)
• Cases:
• Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
• Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment

You may not qualify if:

• 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
• Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
• Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
• 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
• History of esophageal motility disorder
• Currently implanted Linx device

Sponsors & Collaborators

• Lucid Diagnostics, Inc.: lead

Study Sites (38)

Lucid Investigative Site

Birmingham, Alabama, 35294, United States

RECRUITING

Lucid Investigative Site

Orange, California, 92868, United States

RECRUITING

Lucid Investigative Site

Aurora, Colorado, 80045, United States

RECRUITING

Lucid Investigative Site

Englewood, Colorado, 80113, United States

RECRUITING

Lucid Investigative Site

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Lucid Investigative Site

Jacksonville, Florida, 32256, United States

TERMINATED

Lucid Investigative Site

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Lucid Investigative Site

Shreveport, Louisiana, 71105, United States

RECRUITING

Lucid Investigative Site

Baltimore, Maryland, 21287, United States

RECRUITING

Lucid Investigative Site

Boston, Massachusetts, 02215, United States

RECRUITING

Lucid Investigative Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

Lucid Investigative Site

Flowood, Mississippi, 39232, United States

RECRUITING

Lucid Investigative Site

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

Lucid Investigative Site

Omaha, Nebraska, 68124, United States

RECRUITING

Lucid Investigative Site

Lebanon, New Hampshire, 03756, United States

NOT YET RECRUITING

Lucid Investigative Site

New Hyde Park, New York, 11030, United States

RECRUITING

Lucid Investigative Site

Rochester, New York, 14620, United States

NOT YET RECRUITING

Lucid Investigative Site

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Lucid Investigative Site

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Lucid Investigative Site

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Lucid Investigative Site

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Lucid Investigative Site

Providence, Rhode Island, 02903, United States

WITHDRAWN

Lucid Investigative Site

Charleston, South Carolina, 29425, United States

RECRUITING

Lucid Investigative Site

Greenville, South Carolina, 29615, United States

RECRUITING

Lucid Investigative Site

Knoxville, Tennessee, 37909, United States

RECRUITING

Lucid Investigative Site

Nashville, Tennessee, 37212, United States

RECRUITING

Lucid Investigative Site

Austin, Texas, 78712, United States

NOT YET RECRUITING

Lucid Investigative Site

Dallas, Texas, 75246, United States

RECRUITING

Lucid Investigative Site

Houston, Texas, 77030, United States

RECRUITING

Lucid Investigative Site

Salt Lake City, Utah, 84132, United States

RECRUITING

Lucid Investigative Site

Richmond, Virginia, 23249, United States

RECRUITING

Lucid Investigative Site

Richmond, Virginia, 23298, United States

RECRUITING

Lucid Investigative Site

Amsterdam, 1081 HZ, Netherlands

RECRUITING

Lucid Investigative Site

Eindhoven, 5623 EJ, Netherlands

RECRUITING

Lucid Investigative Site

Groningen, 9713 GZ, Netherlands

RECRUITING

Lucid Investigative Site

Nieuwegein, 3435 CM, Netherlands

RECRUITING

Lucid Investigative Site

Nijmegen, 6525 GA, Netherlands

RECRUITING

Lucid Investigative Site

Rotterdam, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michelle McDermott

  Lucid Diagnostics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Alexa Rueda

CONTACT

9157405766; AXR@pavmed.com

Karyms Luna Miller

CONTACT

klm@pavmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, single arm

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 5, 2020
• Study Start: June 18, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (32); NL (6)