Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT06872567
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '6 and 12-month post treatment', 'description': 'Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living.'}, {'measure': 'Serious Adverse Events (SAE)', 'timeFrame': 'Treatment, 1,3,6,9 and 12-month post treatment'}], 'secondaryOutcomes': [{'measure': 'WOMAC total score', 'timeFrame': '9 month post treatment', 'description': 'Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis (Knee OA)']}, 'descriptionModule': {'briefSummary': 'Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has localized knee pain\n* Must be an appropriate candidate for arterial vascular access procedure\n\nExclusion Criteria:\n\n* Known sensitivity or allergy to implant materials\n* Unable or unwilling to comply with study requirements'}, 'identificationModule': {'nctId': 'NCT06872567', 'acronym': 'RESORB', 'briefTitle': 'Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain', 'organization': {'class': 'NETWORK', 'fullName': 'North American Science Associates Ltd.'}, 'officialTitle': 'Resorbable Embolization MicroSpheres for OsteoaRthritis Benefit', 'orgStudyIdInfo': {'id': 'US037031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Corticosteroid Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Device: GAE', 'interventionNames': ['Device: genicular artery embolization']}], 'interventions': [{'name': 'genicular artery embolization', 'type': 'DEVICE', 'description': 'genicular artery embolization', 'armGroupLabels': ['Device: GAE']}, {'name': 'Corticosteroid Injection', 'type': 'DRUG', 'description': 'Corticosteroid Injection', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Ziv J Haskal, MD', 'role': 'CONTACT', 'email': 'haskalembo@gmail.com', 'phone': '16463691570'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North American Science Associates Ltd.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Next Biomedical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}