Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT07118020
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-25
First Post:
2025-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Market Study of Tutopatch In Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device and/or Procedure Related Adverse Events', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Rate of cerebrospinal fluid leakage', 'timeFrame': '12 months'}, {'measure': 'Incidence of re-operation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Craniotomy']}, 'descriptionModule': {'briefSummary': 'This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants in this study will be candidates for craniotomy due to tumor, aneurysm, trauma or other medical conditions recruited from the participating investigator's population", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females of any age undergoing craniotomy\n* Able to return for scheduled study visits\n* Informed consent is able to be obtained\n\nExclusion Criteria:\n\n* Life expectancy \\< 12 months\n* Local cerebral infection\n* Previous surgery at same anatomical site\n* Currently enrolled in another study that would affect validity of study\n* Known hypersensitivity to bovine collagen'}, 'identificationModule': {'nctId': 'NCT07118020', 'briefTitle': 'Post Market Study of Tutopatch In Craniotomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'RTI Surgical'}, 'officialTitle': 'A Prospective Post-Market Study of Tutopatch in Craniotomy', 'orgStudyIdInfo': {'id': 'RTI-2022-02'}}, 'contactsLocationsModule': {'locations': [{'city': 'Salzburg', 'country': 'Austria', 'facility': 'Universitatsklinik fur Neurochirurgie der PMU', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vali d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}