Spots Global Cancer Trial Database for Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
