|

Clinical Utility of WATS3D: A 5-Year Prospective Study

RECRUITINGSponsored by CDx Diagnostics
Actively Recruiting
SponsorCDx Diagnostics
Started2020-04-01
Est. completion2027-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

Barrett EsophagusCancerEsophageal DiseasesEsophageal DysplasiaGastro Esophageal Reflux

Locations1 site

NYU Langone Ambulatory Care
Bethpage, New York, 11714
Matthew J McKinley, M.D.516-758-8600Matthew.McKinley@nyulangone.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.