NCT04312633 Clinical Utility of WATS3D: A 5-Year Prospective Study
| NCT ID | NCT04312633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CDx Diagnostics |
| Condition | Barrett Esophagus |
| Study Type | OBSERVATIONAL |
| Enrollment | 90,000 participants |
| Start Date | 2020-04-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90,000 participants in total. It began in 2020-04-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.
Eligibility Criteria
Inclusion Criteria: * Able to read, comprehend and complete the IRB-approved consent form * Aged 18 or older * Meet one of the following: * Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or * Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or * Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM) * Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included. Exclusion Criteria: * Pregnancy at time of endoscopy * Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines * Medical condition that will likely prohibit completion of a 5 year study
Contact & Investigator
Matthew McKinley, M.D.
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT04312633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barrett Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04312633 currently recruiting?
Yes, NCT04312633 is actively recruiting participants. Contact the research team at khoffman@cdxdiagnostics.com for enrollment information.
Where is the NCT04312633 trial being conducted?
This trial is being conducted at Bethpage, United States.
Who is sponsoring the NCT04312633 clinical trial?
NCT04312633 is sponsored by CDx Diagnostics. The principal investigator is Matthew McKinley, M.D. at NYU Langone Health. The trial plans to enroll 90,000 participants.