WATS3D for the Detection of Esophageal Dysplasia

October 27, 2021 updated by: CDx Diagnostics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Mike Smith

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with known Barrett's Esophagus.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Community GI Group
Diagnostic Test
Other: Diagnostic Test
Academic GI Group
Diagnostic Test
Other: Diagnostic Test
Academic Esophageal Dysplasia and Cancer
Diagnostic Test
Other: Diagnostic Test
Community Barrett's Esophagus Screening
Diagnostic Test
Other: Diagnostic Test
Community Esophageal Dysplasia
Diagnostic Test
Other: Diagnostic Test
Post-Ablation BE and Esophagus Dysplasia
Diagnostic Test
Other: Diagnostic Test
GERD, BE, and Esophageal Dysplasia
Diagnostic Test
Other: Diagnostic Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: up to 18 years
up to 18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CDx Diagnostics

Collaborators

Icahn School of Medicine at Mount Sinai
NYU Langone Health
University of Kansas Medical Center
Temple University
University of Rochester
Rockford Gastroenterology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (ESTIMATE)

January 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDx 103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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