Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT04533932
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2020-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endosonographic Shear Wave Elastography for Liver Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-03', 'releaseDate': '2022-09-16'}], 'estimatedResultsFirstSubmitDate': '2022-09-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2020-08-23', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of fibrosis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Degree of fibrosis based on histological assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '36049537', 'type': 'DERIVED', 'citation': 'Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing liver biopsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for EUS guided liver biopsy\n* Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation\n* Ability to provide informed consent and willing to participate\n\nExclusion Criteria:\n\n* Clinical evidence of cirrhosis which obviates need for liver biopsy\n* Noninvasive lab testing which confirms presence of cirrhosis\n* Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy\n* Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy\n* Thrombocytopenia with platelet count less than 50,000/mL\n* Pregnancy (positive urine pregnancy test in females of childbearing age)\n* Lack of consent'}, 'identificationModule': {'nctId': 'NCT04533932', 'briefTitle': 'Endosonographic Shear Wave Elastography for Liver Stiffness', 'organization': {'class': 'OTHER', 'fullName': "Midwest Veterans' Biomedical Research Foundation"}, 'officialTitle': 'Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study', 'orgStudyIdInfo': {'id': 'MBRF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elastography', 'interventionNames': ['Diagnostic Test: Elastography']}], 'interventions': [{'name': 'Elastography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Endosonographic shear wave elastography', 'armGroupLabels': ['Elastography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Divyanshoo Kohli, MD', 'role': 'CONTACT'}], 'facility': 'Kansas City VA Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'centralContacts': [{'name': 'Divyanshoo R Kohli, MD', 'role': 'CONTACT', 'email': 'divyanshoo.kohli2@va.gov', 'phone': '8168614700'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Biomedical Research Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olympus Corporation of the Americas', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Endoscopy', 'investigatorFullName': 'Divyanshoo Kohli, MD', 'investigatorAffiliation': 'Kansas City Veteran Affairs Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-09-16', 'type': 'RELEASE'}, {'date': '2023-08-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Divyanshoo Kohli, MD, Director of Endoscopy, Kansas City Veteran Affairs Medical Center'}}}}