Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-30 @ 4:01 PM
Study NCT ID:
NCT04963933
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Medical Device to Treat Brain Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': '3-6 months', 'description': 'The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up'}, {'measure': 'Probable benefit', 'timeFrame': '3-6 months', 'description': 'Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Aneurysm']}, 'descriptionModule': {'briefSummary': 'An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms.\n\nThe study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.', 'detailedDescription': 'Patients will be treated with the Nautilus, then will be followed up for up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Patients who present with intracranial aneurysm\n\nExclusion Criteria:\n\n\\* Unstable neurological deficit'}, 'identificationModule': {'nctId': 'NCT04963933', 'briefTitle': 'A Medical Device to Treat Brain Aneurysms', 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoStream Medical'}, 'officialTitle': 'Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)', 'orgStudyIdInfo': {'id': 'CLD-262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients treated with the device', 'description': 'Patients treated with the Nautilus will be followed up', 'interventionNames': ['Device: Nautilus endovascular device']}], 'interventions': [{'name': 'Nautilus endovascular device', 'type': 'DEVICE', 'description': 'Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months', 'armGroupLabels': ['Patients treated with the device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'St. Ivan Rilski University hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'LV-1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Paula Stradina university hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoStream Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}