WATS3D for the Detection of Esophageal Dysplasia

CDx Diagnostics

Status: Completed

Conditions: Esophagus Adenocarcinoma; Barrett Esophagus; Esophageal Dysplasia

Treatments: Other: Diagnostic Test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03008980

CDx 103

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 7 patient groups

Community GI Group

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test

Academic GI Group

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test

Academic Esophageal Dysplasia and Cancer

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test

Community Barrett's Esophagus Screening

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test

Community Esophageal Dysplasia

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test

Post-Ablation BE and Esophagus Dysplasia

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test

GERD, BE, and Esophageal Dysplasia

Description:

Diagnostic Test

Treatment:

Other: Diagnostic Test