WATS3D for the Detection of Esophageal Dysplasia

Completed

• Conditions: Esophageal Dysplasia; Barrett Esophagus; Esophagus Adenocarcinoma
• Interventions: Other: Diagnostic Test

• Registration Number: NCT03008980
• Lead Sponsor: CDx Diagnostics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-01
• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Study Completion: 2018-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Community Barrett's Esophagus Screening	Diagnostic Test	Diagnostic Test
Academic Esophageal Dysplasia and Cancer	Diagnostic Test	Diagnostic Test
GERD, BE, and Esophageal Dysplasia	Diagnostic Test	Diagnostic Test
Community GI Group	Diagnostic Test	Diagnostic Test
Academic GI Group	Diagnostic Test	Diagnostic Test
Community Esophageal Dysplasia	Diagnostic Test	Diagnostic Test
Post-Ablation BE and Esophagus Dysplasia	Diagnostic Test	Diagnostic Test

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mike Smith; 🇺🇸 Philadelphia, Pennsylvania, United States