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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015389
• Other study ID #: CDx 810
• Status: Completed
• Start date: September 27, 2017
• Est. completion date: February 18, 2019

Study information

• Verified date: July 2020
• Source: CDx Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma
• Esophageal Dysplasia

Intervention

Procedure:
• Diagnostic Test
WATS3D brush biopsy

Locations

Country	Name	City	State
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
CDx Diagnostics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.		up to 2 years
Secondary	Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.		up to 2 years