Clinical trial · Observational
Clinical Utility of WATS3D: A 5-Year Prospective Study
CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Diseases | — | UNRESOLVED | — |
| Esophageal Dysplasia | Esophageal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Gastro Esophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary Outcome Measure:
- timeFrame
- 5 years
- description
- Clinical Utility of WATS3D as determined by how many patients undergo increased surveillance, radiofrequency ablation and placement on PPIs.
Secondary outcomes (1)
- measure
- Secondary Outcome Measure:
- timeFrame
- 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available