Registry to evaluate biopsy methods for esophageal conditions
Official title: CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry
Run by CDx Diagnostics · NCT04312633 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90000 (estimated) |
| Sponsor | CDx Diagnostics Industry-sponsored |
| Locations | 1 site (Bethpage, New York) |
| Status | Recruiting |
| Started | April 1, 2020 |
| Main results expected | November 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT04312633 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 or older with heartburn, Barrett's esophagus, or those undergoing surveillance after endoscopic eradication treatments.
✕Probably not a fit
Patients who are pregnant or have unresolved substance dependencies that affect their ability to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using similar biopsy techniques for esophageal conditions, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predictors of symptom improvement after laparoscopic fundoplication
This study tests what preoperative factors help predict which GERD patients will feel better after laparoscopic fundoplication.
-
Medical AI fine-tuning platform for major diseases
This study tests a smart AI system that uses hospital data to help diagnose and guide care for patients with chronic gastritis, gastric cancer, reflux, coronary artery disease, or stroke.
-
Potassium-Competitive Acid Blockers in Barrett’s Esophagus on PPI Therapy
This study tests whether vonoprazan, a potassium-competitive acid blocker, can better reduce acid reflux in adults with nondysplastic Barrett’s esophagus who are already taking a daily PPI.
-
Multicenter chest X-ray screening for thoracic diseases
This project will test whether routine chest X-rays can detect thoracic problems in adults who come for routine health examinations.
-
A registry for adults with esophageal movement and reflux problems.
This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.
-
How common symptomatic gastroesophageal reflux is in Czech children aged 8–9 and 12–13
This project will see how common symptomatic GERD is in Czech children aged 8–9 and 12–13 by using school questionnaires and follow-up medical testing for kids who report reflux symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.