Registry to evaluate biopsy methods for esophageal conditions
CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry
CDx Diagnostics · NCT04312633
This study is trying to see how two different biopsy methods during endoscopy can help doctors make better treatment decisions for patients with esophageal conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CDx Diagnostics (industry) |
| Locations | 1 site (Bethpage, New York) |
| Trial ID | NCT04312633 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry to collect data on two biopsy methods used during upper endoscopy: forceps biopsies and brush biopsies. It will assess how the results from these methods influence clinical decisions regarding patient care and treatment over a five-year period. The study will also investigate the predictive value of these biopsy techniques in identifying patients at risk for Barrett's esophagus and its progression to precancerous conditions or cancer. Participants will be those undergoing standard clinical care with both biopsy methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with heartburn, Barrett's esophagus, or those undergoing surveillance after endoscopic eradication treatments.
Not a fit: Patients who are pregnant or have unresolved substance dependencies that affect their ability to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the early detection and management of Barrett's esophagus and related conditions, potentially reducing the risk of esophageal cancer.
How similar studies have performed: Other studies have shown promise in using similar biopsy techniques for esophageal conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to read, comprehend and complete the IRB-approved consent form * Aged 18 or older * Meet one of the following: * Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or * Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or * Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM) * Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included. Exclusion Criteria: * Pregnancy at time of endoscopy * Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines * Medical condition that will likely prohibit completion of a 5 year study
Where this trial is running
Bethpage, New York
- NYU Langone Ambulatory Care — Bethpage, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Matthew McKinley, M.D. — NYU Langone Health
- Study coordinator: Karen Hoffman, M.D.
- Email: khoffman@cdxdiagnostics.com
- Phone: 845-777-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Barrett Esophagus, Gastro Esophageal Reflux, Esophageal Dysplasia, Esophageal Diseases