WATS3D for the Detection of Esophageal Dysplasia

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008980
• Other study ID #: CDx 103
• Status: Completed
• Start date: May 2014
• Est. completion date: December 2018

Study information

• Verified date: October 2021
• Source: CDx Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2018
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Dysplasia
• Esophagus Adenocarcinoma

Intervention

Other:
• Diagnostic Test

Locations

Country	Name	City	State
United States	Mike Smith	Philadelphia	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
CDx Diagnostics	Icahn School of Medicine at Mount Sinai, NYU Langone Health, Rockford Gastroenterology Associates, Temple University, University of Kansas Medical Center, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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