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

NCT ID: NCT03015389

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-27
• Study Completion Date: 2019-02-18

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Barrett's associated esophageal dysplasia

Diagnostic Test

Intervention Type: PROCEDURE

WATS3D brush biopsy

Interventions

Diagnostic Test

WATS3D brush biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients age: ≥ 18 years

2. Patients should have a history of Barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology

3. Willingness to undergo both WATS3D and random forceps biopsies while undergoing conventional EGD with sedation

4. Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation

5. Only patients who no visible mucosal abnormalities at the time that they undergo both random forceps biopsies and WATS3D testing of the esophagus will be included in this study

Exclusion Criteria

1. Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000

2. The subject is pregnant or planning a pregnancy during the study period

3. History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR)

4. Patients who have undergone endoscopic ablative therapies

5. Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines

6. Study patients with inadequate WATS3D specimens will not undergo a repeat brush biopsy test and will be excluded from the study

7. BE length < 1 cm or > 10 cm

8. Patients within six weeks of receiving targeted forceps biopsies and/or EMR

9. Patients with visible mucosal abnormality at the time of the WATS3D and random biopsy testing

10. Patients with visible lesions that are either submucosal or covered with a clinically intact epithelium

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CDx Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raf Bisschops, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Leuven, Dept. of Gastroenterology

Cesare Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Nuovo Regina Margherita Hospital

Locations

UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

Countries

Belgium

Other Identifiers

CDx 810

Identifier Type: -

Identifier Source: org_study_id