Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04312633
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2020-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Utility of WATS3D: A 5-Year Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure:', 'timeFrame': '5 years', 'description': 'Clinical Utility of WATS3D as determined by how many patients undergo increased surveillance, radiofrequency ablation and placement on PPIs.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome Measure:', 'timeFrame': '5 years', 'description': "Incremental detection yield due to WATS sampling as number of patients who have Barrett's Esophagus and Esophageal Dysplasia determined by WATS and missed by forceps biopsies."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Barrett Esophagus', 'Gastro Esophageal Reflux', 'Esophageal Dysplasia', 'Esophageal Diseases']}, 'descriptionModule': {'briefSummary': '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 the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.', 'detailedDescription': "This study will look at the impact of the brush biopsy results on your doctor's decisions about your future care and treatment.\n\nIn addition , by recording the results of all your biopsies over 5 years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer.\n\nYou are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of you standard clinical care, and you are at least 18 years old."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or\n* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or\n* 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)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read, comprehend and complete the IRB-approved consent form\n* Aged 18 or older\n* Meet one of the following:\n* Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or\n* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or\n* 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)\n* Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included.\n\nExclusion Criteria:\n\n* Pregnancy at time of endoscopy\n* 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\n* Medical condition that will likely prohibit completion of a 5 year study'}, 'identificationModule': {'nctId': 'NCT04312633', 'briefTitle': 'Clinical Utility of WATS3D: A 5-Year Prospective Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'CDx Diagnostics'}, 'officialTitle': 'CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry', 'orgStudyIdInfo': {'id': 'CDx 906'}}, 'contactsLocationsModule': {'locations': [{'zip': '11714', 'city': 'Bethpage', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew J McKinley, M.D.', 'role': 'CONTACT', 'email': 'Matthew.McKinley@nyulangone.org', 'phone': '516-758-8600'}], 'facility': 'NYU Langone Ambulatory Care', 'geoPoint': {'lat': 40.74427, 'lon': -73.48207}}], 'centralContacts': [{'name': 'Karen Hoffman, M.D.', 'role': 'CONTACT', 'email': 'khoffman@cdxdiagnostics.com', 'phone': '845-777-7000'}, {'name': 'William Cuddy', 'role': 'CONTACT', 'email': 'wcuddy@cdxdiagnostics.com', 'phone': '845-368-7452'}], 'overallOfficials': [{'name': 'Matthew McKinley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CDx Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}