CLUE: CLinical Utility Study of EsoGuard

Description

Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.

Conditions

Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma

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Study Overview

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Study Details

Study overview

Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.

CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)

CLUE: CLinical Utility Study of EsoGuard

Condition
Barrett Esophagus
Intervention / Treatment

-

Contacts and Locations

Heber Springs

Arkansas Heartburn Treatment Center, Heber Springs, Arkansas, United States, 72543

Arvada

Arvada West Family Medicine,, Arvada, Colorado, United States, 80004

Littleton

Colorado Primary Healthcare, Littleton, Colorado, United States, 80120

Savannah

Savii Health, Savannah, Georgia, United States, 31406

Dallas

James E Race, Dallas, Texas, United States, 75224

Harlingen

Texas Digestive Specialists, Harlingen, Texas, United States, 78550

Shenandoah

Gastroenterology Partners of North Houston, PLLC, Shenandoah, Texas, United States, 77384

Lindon

Premier Family Medical, Lindon, Utah, United States, 84042

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. Individuals in whom the clinical decision has been made to screen for BE using EC/EG
  • 2. Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.
  • 1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
  • 2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
  • 3. Inability to provide written informed consent or participate in the required follow up

Ages Eligible for Study

12 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lucid Diagnostics, Inc.,

Gisella Lopez, STUDY_DIRECTOR, Lucid Diagnostics

Study Record Dates

2023-09-29