Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT07258069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], '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': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence or progression of subdural hematoma', 'timeFrame': 'within 3 months', 'description': 'Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH.\n\n\\*\\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.'}], 'secondaryOutcomes': [{'measure': 'Efficacy (1. Time)', 'timeFrame': 'V1, preoperatively (baseline visit)', 'description': 'Time period from symptoms to embolization'}, {'measure': 'Efficacy (2. Time)', 'timeFrame': 'V2, surgery (index procedure)', 'description': 'Time period from burr-hole drainage to embolization'}, {'measure': 'Efficacy (3. Time)', 'timeFrame': '6 months', 'description': 'Time period from embolization to recurrence'}, {'measure': 'Efficacy (4. Hematoma thickness)', 'timeFrame': 'at V4: 3 months and V5: 6 months compared to baseline', 'description': 'Change in hematoma thickness'}, {'measure': 'Efficacy (5. Change in midlind shift)', 'timeFrame': 'at V4: 3 months and V5: 6 months', 'description': 'Change in midline shift compared to baseline'}, {'measure': 'Efficacy (6. Cognitive assessment)', 'timeFrame': 'V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months', 'description': 'Mini-Mental State Examination (MMSE) from 0 (severe cognitive impairment) to 30 (no cognitive impairment)'}, {'measure': 'Quality of life, EQ-5D', 'timeFrame': 'V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months', 'description': 'assessed by EQ-5D scale from 0 (worst health) to 100 (best health)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subdural Hematoma', 'Subdural Hematoma, Chronic']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH)\n* Completed documented informed consent\n* Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days)\n\nExclusion Criteria:\n\n* Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment\n* Need craniotomy\n* Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses)\n* Coagulation dysfunction with INR\\>1.8 and/or platelet count \\<80x109 /L\n* Allergic reactions to essential medicines to do angiography\n* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study\n* Participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT07258069', 'acronym': 'HARMONY', 'briefTitle': 'Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)', 'orgStudyIdInfo': {'id': 'AAG-O-H-25118'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Histoacryl®', 'type': 'DEVICE', 'description': 'Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marta Soteras, Dr.', 'role': 'CONTACT', 'email': 'studies@aesculap.de', 'phone': '+34 935 8662', 'phoneExt': '00'}, {'name': 'Yumiko Okaniva, Dr.', 'role': 'CONTACT', 'email': 'gen.jp@bbraun.jp', 'phone': '+81 3814', 'phoneExt': '2525'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}