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Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma

NCT03015389 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2020-07-23

No results posted yet for this study

Summary

This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.

Conditions

  • Barrett Esophagus
  • Esophageal Dysplasia
  • Esophageal Adenocarcinoma

Interventions

PROCEDURE

Diagnostic Test

WATS3D brush biopsy

Sponsors & Collaborators

  • CDx Diagnostics

    lead INDUSTRY

Principal Investigators

  • Raf Bisschops, MD · University Hospitals Leuven, Dept. of Gastroenterology

  • Cesare Hassan, MD · Nuovo Regina Margherita Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-27
Primary Completion
2019-02-18
Completion
2019-02-18

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03015389 on ClinicalTrials.gov