Evaluating the impact of EsoGuard testing on endoscopy referrals for Barrett Esophagus
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
This study is testing how the results from EsoGuard testing affect whether doctors refer patients for endoscopy when screening for Barrett Esophagus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Sponsor | PAVmed Inc. Industry-sponsored |
| Locations | 8 sites (Heber Springs, Arkansas and 7 other locations) |
| Trial ID | NCT06030180 on ClinicalTrials.gov |
What this trial studies
This study utilizes real-world data from the commercial use of EsoGuard testing, which is performed on samples collected using the EsoCheck device. It aims to assess how the results of EsoGuard influence healthcare providers' decisions regarding referrals for endoscopy. Additionally, the study will evaluate patient compliance with recommendations for upper endoscopy and explore the relationship between compliance and positive EsoGuard results. The study focuses on individuals who are being screened for Barrett Esophagus according to established clinical guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are being screened for Barrett Esophagus according to the 2022 ACG guidelines or AGA best practice advice.
Not a fit: Patients who do not meet the eligibility criteria for Barrett Esophagus screening or cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and early detection of Barrett Esophagus and related conditions, potentially leading to better patient outcomes.
How similar studies have performed: While this approach is based on existing guidelines, the specific application of EsoGuard testing in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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
Where this trial is running
Heber Springs, Arkansas and 7 other locations
- Arkansas Heartburn Treatment Center — Heber Springs, Arkansas, United States (Recruiting)
- Arvada West Family Medicine, — Arvada, Colorado, United States (Recruiting)
- Colorado Primary Healthcare — Littleton, Colorado, United States (Recruiting)
- Savii Health — Savannah, Georgia, United States (Recruiting)
- James E Race — Dallas, Texas, United States (Recruiting)
- Texas Digestive Specialists — Harlingen, Texas, United States (Not_yet_recruiting)
- Gastroenterology Partners of North Houston, PLLC — Shenandoah, Texas, United States (Recruiting)
- Premier Family Medical — Lindon, Utah, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Alexa Rueda
- Email: axr@pavmed.com
- Phone: 9157405766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.