Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT07291427
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Subdural Hematoma Embolization With Detachable Coils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D006408', 'term': 'Hematoma, Subdural'}], 'ancestors': [{'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '180 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hematoma volume', 'timeFrame': '180 days', 'description': 'Change in hematoma volume based on CT imaging'}, {'measure': 'Change in maximal thickness', 'timeFrame': '180 days', 'description': 'Change in maximal thickness based on CT imaging'}, {'measure': 'Change in midline shift', 'timeFrame': '180 days', 'description': 'Change in midline shift (mm) based on CT imaging'}, {'measure': 'Number of periprocedural major disabling stroke or any death', 'timeFrame': '30 days', 'description': 'Number of periprocedural major disabling stroke or any death'}, {'measure': 'Number of participants with symptomatic recurrence progression requiring retreatment', 'timeFrame': '180 days', 'description': 'Number of participants with symptomatic recurrence progression of the SDH requiring retreatment'}], 'secondaryOutcomes': [{'measure': 'Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE', 'timeFrame': '180 days', 'description': 'Number of Adverse events and serious adverse events related to the device as assessed by an independent medical monitor'}, {'measure': 'Number of Acute successful embolization of the target vessel', 'timeFrame': 'Immediately post-procedure', 'description': 'Determination of successful embolization based on angiographic imaging'}, {'measure': 'Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L)', 'timeFrame': '180 days', 'description': 'The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L, each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from \\<0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Lower scores indicate a higher QoL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Subdural hemorrhage', 'Coils', 'Middle meningeal artery'], 'conditions': ['Chronic Subdural Hemorrhage (cSDH)']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).', 'detailedDescription': 'The primary objective of this observational registry study is to assess the safety and efficacy of Balt Coils as an adjunct to middle meningeal artery (MMA) embolization in a real-world setting among patients undergoing treatment for chronic subdural hematoma (cSDH), and explore correlations between patient characteristics, clinical characteristics, and outcomes. By collecting comprehensive, real-world data, the registry will characterize procedural inputs, document clinical and radiographic outcomes, and explore variation in technique and practice setting. The overarching goal is to generate a more complete understanding of Middle Meningeal Artery Embolization (MMAE) in diverse clinical environments, inform future prospective studies, and guide evidence-based adoption of this evolving therapy. Patients may be treated with Balt coils regardless of enrollment in the study as the decision to place the coils should be made independently as per standard of care and prior to enrollment in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥ 18\n* Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed.\n* A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study.\n* Signed informed consent obtained by patient or Legal Authorized Representative (LAR)\n\nExclusion criteria:\n\n* Primary acute SDH\n* Prior MMAE in target territory\n* Premorbid mRS \\> 3\n* Common carotid stenosis \\>70% or prior carotid stent placement\n* Significant medical contraindication to angiography (kidney failure/disease)\n* Anatomical variations that would make MMA embolization difficult or unsafe\n* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints\n* Pregnancy\n* Life expectancy ≤ 1 year'}, 'identificationModule': {'nctId': 'NCT07291427', 'acronym': 'SEED', 'briefTitle': 'Chronic Subdural Hematoma Embolization With Detachable Coils', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils', 'orgStudyIdInfo': {'id': 'STUDY-25-01365'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with cSDH', 'description': 'All participants enrolled will be treated with the Balt coils.\n\n1. MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment.\n2. MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as:\n\n 1. MMA embolization in combination with Balt coils post-surgical debridement, or\n 2. MMA embolization using Balt coils alone, pre- or post-surgical debridement.', 'interventionNames': ['Device: Balt coils: (Balt USA, LLC)', 'Procedure: MMA embolization']}], 'interventions': [{'name': 'Balt coils: (Balt USA, LLC)', 'type': 'DEVICE', 'otherNames': ['Optima', 'OptiMax', 'OptiBlock', 'Optima series line extensions'], 'description': 'MMA embolization utilizing Balt Coils', 'armGroupLabels': ['Participants with cSDH']}, {'name': 'MMA embolization', 'type': 'PROCEDURE', 'description': 'surgical or bedside evacuation\n\npre or post-surgical debridement', 'armGroupLabels': ['Participants with cSDH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Sukaina Davdani', 'role': 'CONTACT', 'email': 'Sukaina.Davdani@mountsinai.org'}, {'name': 'Sydney Edwards', 'role': 'CONTACT', 'email': 'sydney.edwards@mountsinai.org'}, {'name': 'Christopher Kellner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Sukaina Davdani', 'role': 'CONTACT', 'email': 'Sukaina.Davdani@mountsinai.org', 'phone': '(212) 241-2524'}, {'name': 'Sydney Edwards', 'role': 'CONTACT', 'email': 'Sydney.Edwards@mountsinai.org', 'phone': '(212) 241-2524'}], 'overallOfficials': [{'name': 'Christopher Kellner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Benjamin Yim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'John Muir Health'}, {'name': 'Alexander Coon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carondelet Neurological Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. Data that will be shared and published will be that of all participants combined to protect individual patient privacy and confidentiality."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'John Muir Health', 'class': 'OTHER'}, {'name': 'Carondelet Neurological Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christopher P Kellner', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}