Clinical Utility of WATS3D: A 5-Year Prospective Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCDx Diagnostics
About this trial
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
This trial does not accept healthy volunteersQualifiers
Able to read, comprehend and complete the IRB-approved consent form
Aged 18 or older
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
Disqualifiers
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
Trial population
* 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Primary Outcome Measure:
Clinical Utility of WATS3D as determined by how many patients undergo increased surveillance, radiofrequency ablation and placement on PPIs.
Time frame
5 yearsSecondary outcomes
1
Secondary Outcome Measure:
Incremental detection yield due to WATS sampling as number of patients who have Barrett's Esophagus and Esophageal Dysplasia determined by WATS and missed by forceps biopsies.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov