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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Device, Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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

• Indicated for surveillance EGD or for therapeutic EGD

• Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD

Locations
United States
Alabama
Lucid Investigative Site
Recruiting
Birmingham
California
Lucid Investigative Site
Recruiting
Orange
Colorado
Lucid Investigative Site
Recruiting
Aurora
Lucid Investigative Site
Recruiting
Englewood
Washington, D.c.
Lucid Investigative Site
Recruiting
Washington
Florida
Lucid Investigative Site
Terminated
Jacksonville
Illinois
Lucid Investigative Site
Not yet recruiting
Chicago
Louisiana
Lucid Investigative Site
Recruiting
Shreveport
Massachusetts
Lucid Investigative Site
Recruiting
Boston
Maryland
Lucid Investigative Site
Recruiting
Baltimore
Michigan
Lucid Investigative Site
Recruiting
Ann Arbor
Missouri
Lucid Investigative Site
Not yet recruiting
Saint Louis
Mississippi
Lucid Investigative Site
Recruiting
Flowood
North Carolina
Lucid Investigative Site
Recruiting
Chapel Hill
Nebraska
Lucid Investigative Site
Recruiting
Omaha
New Hampshire
Lucid Investigative Site
Not yet recruiting
Lebanon
New York
Lucid Investigative Site
Recruiting
New Hyde Park
Lucid Investigative Site
Not yet recruiting
Rochester
Oregon
Lucid Investigative Site
Not yet recruiting
Portland
Pennsylvania
Lucid Investigative Site
Recruiting
Philadelphia
Lucid Investigative Site
Not yet recruiting
Philadelphia
Rhode Island
Lucid Investigative Site
Withdrawn
Providence
South Carolina
Lucid Investigative Site
Recruiting
Charleston
Lucid Investigative Site
Recruiting
Greenville
Tennessee
Lucid Investigative Site
Recruiting
Knoxville
Lucid Investigative Site
Recruiting
Nashville
Texas
Lucid Investigative Site
Not yet recruiting
Austin
Lucid Investigative Site
Recruiting
Dallas
Lucid Investigative Site
Recruiting
Houston
Utah
Lucid Investigative Site
Recruiting
Salt Lake City
Virginia
Lucid Investigative Site
Recruiting
Richmond
Lucid Investigative Site
Recruiting
Richmond
Other Locations
Netherlands
Lucid Investigative Site
Recruiting
Amsterdam
Lucid Investigative Site
Recruiting
Eindhoven
Lucid Investigative Site
Recruiting
Groningen
Lucid Investigative Site
Recruiting
Nieuwegein
Lucid Investigative Site
Recruiting
Nijmegen
Lucid Investigative Site
Recruiting
Rotterdam
Contact Information
Primary
Michelle McDermott
MMM@LucidDx.com
212-949-4319
Time Frame
Start Date: June 18, 2020
Estimated Completion Date: December 2022
Participants
Target number of participants: 470
Treatments
Experimental: EsoCheck and EsoGuard vs. EGD with or without biopsies
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
Related Therapeutic Areas
Sponsors
Leads: Lucid Diagnostics, Inc.

This content was sourced from clinicaltrials.gov

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