WATS3D for the Detection of Esophageal Dysplasia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Barrett Esophagus, Esophageal Dysplasia, Esophagus Adenocarcinoma

Intervention / Treatment
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* Other: Diagnostic Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Community GI Group<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |
| Academic GI Group<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |
| Academic Esophageal Dysplasia and Cancer<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |
| Community Barrett's Esophagus Screening<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |
| Community Esophageal Dysplasia<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |
| Post-Ablation BE and Esophagus Dysplasia<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |
| GERD, BE, and Esophageal Dysplasia<br>Diagnostic Test | Other: Diagnostic Test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings. |  | up to 18 years |