Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-02 @ 5:05 AM
Study NCT ID:
NCT05818150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
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'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint', 'timeFrame': '6 months', 'description': 'Clinical Success defined as ≥50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale from baseline to 6 months without the need for additional intervention.'}, {'measure': 'Primary Safety Endpoint', 'timeFrame': '6 months', 'description': 'Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.'}], 'secondaryOutcomes': [{'measure': 'Subjects achieving Clinical Success', 'timeFrame': '3, 12, and 24 months', 'description': 'Number of subjects achieving Clinical Success'}, {'measure': 'Numerical rating scale (NRS)', 'timeFrame': 'baseline, 3, 6, 12 and 24 months', 'description': 'Pain score assessed using numerical rating scale (NRS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['genicular artery embolization', 'GAE', 'knee embolization', 'knee OA'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '40050421', 'type': 'DERIVED', 'citation': 'Bent C, McAsey CJ, Bagla S. Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary. Cardiovasc Intervent Radiol. 2025 Apr;48(4):551-558. doi: 10.1007/s00270-025-03994-z. Epub 2025 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.', 'detailedDescription': 'This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nProvides written informed consent\n\nAge ≥21 years\n\nMild to severe knee pain, defined as a WOMAC Pain score of ≥8 out of 20 (in the target knee)\n\nPain refractory to conservative therapies for at least 90 days prior to enrollment/randomization.\n\nKellgren-Lawrence grade 1, 2, 3 or 4\n\nKey Exclusion Criteria:\n\nPlanned major surgical or endovascular procedures ≤ 30 days after the index procedure.\n\nAdvanced atherosclerosis\n\nKnown history of rheumatoid or infectious arthritis.\n\nPrior knee replacement surgery of the target knee.'}, 'identificationModule': {'nctId': 'NCT05818150', 'acronym': 'MOTION', 'briefTitle': 'GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': 'Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study', 'orgStudyIdInfo': {'id': 'GAE-P3-22-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genicular artery embolization with Embosphere Microspheres', 'description': 'Device: Embosphere Microspheres\n\nEmbolic Agent: Embosphere Microspheres', 'interventionNames': ['Device: Embosphere Microspheres']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid Injection of the knee', 'description': 'Drug: Corticosteroid injection', 'interventionNames': ['Drug: Corticosteroid injection']}], 'interventions': [{'name': 'Embosphere Microspheres', 'type': 'DEVICE', 'otherNames': ['Genicular artery embolization'], 'description': 'Embolic Agent: Embosphere Microspheres', 'armGroupLabels': ['Genicular artery embolization with Embosphere Microspheres']}, {'name': 'Corticosteroid injection', 'type': 'DRUG', 'otherNames': ['Triamcinolone or methylprednisolone'], 'description': 'Corticosteroid injection', 'armGroupLabels': ['Corticosteroid Injection of the knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Care Long Beach Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '22010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30337', 'city': 'College Park', 'state': 'Georgia', 'country': 'United States', 'facility': 'Biotech Clinical Research/ Georgia Vascular Institute', 'geoPoint': {'lat': 33.65344, 'lon': -84.44937}}, {'zip': '60201', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63103', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08205', 'city': 'Galloway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Medical Imaging', 'geoPoint': {'lat': 39.48788, 'lon': -74.47598}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Health', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Atlas Interventional', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '27617', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Prostate Centers USA', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27330', 'city': 'Sanford', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Sunrise Vascular Center', 'geoPoint': {'lat': 35.47988, 'lon': -79.1803}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73134', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cardiovascular Health Clinic', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '22043', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Prostate Centers USA', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '20191', 'city': 'Leesburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Prostate Centers USA', 'geoPoint': {'lat': 39.11566, 'lon': -77.5636}}, {'city': 'Liverpool', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'city': 'Passo Fundo', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Passo Fundo', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'H2X OC1', 'city': 'Montreal', 'country': 'Canada', 'facility': "CHUM - Centre hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Takapuna', 'country': 'New Zealand', 'facility': 'North Shore Hospital/ Te Whatu Ora - Waitemata', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'University Hospitals Dorset', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'NP44 8YN', 'city': 'Cwmbran', 'country': 'United Kingdom', 'facility': 'Grange University Hospital', 'geoPoint': {'lat': 51.65446, 'lon': -3.02281}}], 'overallOfficials': [{'name': 'Sandeep Bagla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prostate Centers, USA'}, {'name': 'Craig J McAsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anderson Orthopedic Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}