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Active Clinical Trials

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

Active NCT:
03015389
Canonsburg Hospital
Canonsburg Hospital

Peters Township Health + Wellness Pavilion
Peters Township Health + Wellness Pavilion

West Penn Hospital
West Penn Hospital

Sponsor: 
CDx Diagnostics
Contact: 

For more information, please contact Mara Yerk at 412-578-5393 or Mara.Yerk@ahn.org.

CDX 810: The Evaluation of Patients with Esophageal and Foregut Disorders with WATS (Wide Area Transepithelial Sample with 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy

Purpose: 

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.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Sampling Method:  Probability Sample

Study Population

Barrett's associated esophageal dysplasia

Inclusion Criteria:

Patients age: ≥ 18 years

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

Willingness to undergo both WATS3D and random 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 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:

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

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

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

Patients who have undergone endoscopic ablative therapies

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

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

BE length < 1 cm or > 10 cm

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

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

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