Registry for patients undergoing esophageal cancer screening
A Multicenter, Prospective, Open-Label Registry Study of the Utilization of EsoGuard, on Samples Collected Using EsoCheck, in an At-Risk Population Undergoing Standard of Care Screening for, and Management of, Previously Undiagnosed Barrett's Esophagus and/or Esophageal Adenocarcinoma
This study is collecting information from patients getting screened for Barrett Esophagus and Esophageal Adenocarcinoma using a new test to see how well it works and how patients feel about the process.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | PAVmed Inc. Industry-sponsored |
| Locations | 1 site (Lake Forest, California) |
| Trial ID | NCT05965999 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study aims to collect data on patients undergoing screening for Barrett Esophagus (BE) and Esophageal Adenocarcinoma (EAC) using the EsoGuard test and EsoCheck device. The study will gather information on patient demographics, medical history, risk factors, and clinical management following the screening. Data will be recorded in an electronic system to assess the effectiveness and patient tolerance of the EsoCheck procedure and the subsequent diagnostic results. The goal is to improve understanding of BE and EAC management based on real-world clinical practices.
Who should consider this trial
Good fit: Ideal candidates include males and females who are being screened for Barrett Esophagus or Esophageal Adenocarcinoma and can provide informed consent.
Not a fit: Patients who cannot provide informed consent or do not meet the eligibility criteria for the EsoCheck device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management strategies for Barrett Esophagus and Esophageal Adenocarcinoma.
How similar studies have performed: While this study utilizes established screening methods, the specific observational approach may provide novel insights into patient management and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and Females who have provided informed consent for prospective registry participation 2. Subject in whom the clinical decision has been made to screen for BE/EAC using EsoGuard testing on samples collected with EsoCheck Exclusion Criteria: 1. Inability to provide written informed consent 2. Subjects who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
Where this trial is running
Lake Forest, California
- Lucid Dx — Lake Forest, California, United States (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.