Clinical trial · Observational
WATS3D for the Detection of Esophageal Dysplasia
Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study
- 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)
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.
Conditions
Conditions (3)
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 Dysplasia | Esophageal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Esophagus Adenocarcinoma | Esophageal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- label
- Community GI Group
- description
- Diagnostic Test
- interventionNames
- Other: Diagnostic Test
- label
- Academic GI Group
- description
- Diagnostic Test
- interventionNames
- Other: Diagnostic Test
- label
- Academic Esophageal Dysplasia and Cancer
- description
- Diagnostic Test
- interventionNames
- Other: Diagnostic Test
- label
- Community Barrett's Esophagus Screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age: ≥ 18 years * Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade) * Willingness to undergo both WATS and forceps biopsies while undergoing conventional EGD with sedation * Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation * Only patients who undergo both forceps biopsies and WATS of the esophagus will be included in this study Exclusion criteria: * Coagulopathy with an international normalized ratio above 2.0; * Thrombocytopenia with platelet counts below 50,000 * History of prior esophageal ablation therapies, esophageal or gastric surgery * Unresolved drug or alcohol dependency * Pregnancy or planned pregnancy during the study period * Patients found to have a BE length less than 1 cm or greater than 10 cm * Patients with any visible lesions greater than 10 mm
References
Publications (1)
- DERIVEDVennalaganti PR, Kaul V, Wang KK, Falk GW, Shaheen NJ, Infantolino A, Johnson DA, Eisen G, Gerson LB, Smith MS, Iyer PG, Lightdale CJ, Schnoll-Sussman F, Gupta N, Gross SA, Abrams J, Haber GB, Chuttani R, Pleskow DK, Kothari S, Goldblum JR, Zhang Y, Sharma P. Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27. PMID 28757316