Status:
RECRUITING
Clinical Utility of WATS3D: A 5-Year Prospective Study
Lead Sponsor:
CDx Diagnostics
Conditions:
Barrett Esophagus
Gastro Esophageal Reflux
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is...
Detailed Description
This study will look at the impact of the brush biopsy results on your doctor's decisions about your future care and treatment. In addition , by recording the results of all your biopsies over 5 year...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
90000 Patients enrolled
Trial Details
Trial ID
NCT04312633
Start Date
April 1 2020
End Date
November 1 2027
Last Update
August 21 2024
Active Locations (1)
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1
NYU Langone Ambulatory Care
Bethpage, New York, United States, 11714