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Spots Global Cancer Trial Database for Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE

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Trial Identification

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

Official Title: A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population

Study ID: NCT04293458

Interventions

EsoGuard

Study Description

Brief Summary: 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.

Detailed Description: This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.

Keywords

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: Yes

Locations

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

Lucid Investigative Site, Valladolid, , Spain

Lucid Investigative Site, Zaragoza, , Spain

Contact Details

Name: Michelle McDermott

Affiliation: Lucid Diagnostics

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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