WATS3D for the Detection of Esophageal Dysplasia

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.

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Key information

Conditions

Barrett Esophagus Adenocarcinoma Of Esophagus Digestive System Diseases Esophageal Diseases Esophageal Dysplasia Esophagus Adenocarcinoma Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mike Smith

Philadelphia, Pennsylvania, 19140, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test

Other

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

CDx Diagnostics

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2018
First posted: Jan 4, 2017
Registry last updated: Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed