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Barrett Esophagus
+3

Clinical Utility of WATS3D: A 5-Year Prospective Study

Sponsored by CDx Diagnostics

About this trial

Last updated 3 years ago

Study ID

CDx 906

Status

Recruiting

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status

Recruiting