Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05441618
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2022-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D002528', 'term': 'Cerebellar Neoplasms'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015192', 'term': 'Infratentorial Neoplasms'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Cerebrospinal Fluid Leakage', 'timeFrame': 'at one follow-up ≥ 3 months after surgery', 'description': 'A Cerebrospinal Fluid (CSF) leakage needs to be confirmed by radiological image evaluation (computed tomography scan, CT or magnetic resonance imaging scan, MRI). It will be documented if the CSF leak was clinically evident or not. A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice (e.g., rhinorrhea or otorrhea) or as subcutaneous visible and / or palpable fluid accumulation next to or at the site of surgical incision suspected to be CSF. A non-clinically evident CSF leak is defined as CSF accumulation which could be detected only by radiological image evaluation (CT / MRI).'}], 'secondaryOutcomes': [{'measure': 'Incidence of re-operations with product relationship', 'timeFrame': 'at one follow-up ≥ 3 months after surgery', 'description': 'e.g. caused by infection, foreign-body-reaction/ hypersensitivity against proteins of bovine origin/ allergic reactions to proteins of bovine origin'}, {'measure': 'Incidence of further (serious) adverse events in chronologic sequence', 'timeFrame': 'intra- and postoperative, until follow-up ≥ 3 months after surgery', 'description': 'Number of further serious adverse events e.g. meningitis, surgical site infection, inflammation rate, hematoma - with focus on events with (possible) relation to the investigational product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lyoplant', 'Retrospective Study', 'Decompressive Craniectomy', 'Cerebral Dura Defect', 'Cerebellar Dura Defect', 'Spinal Dura Defects'], 'conditions': ['Tumor, Cerebral Ventricle', 'Tumor, Cerebellar', 'Aneurysm Cerebral', 'Trauma, Brain']}, 'descriptionModule': {'briefSummary': 'Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient files from adult patients with indication of surgical diagnosis (e.g. decompressive craniectomy, tumor, aneurysm, trauma etc.) in a single center are revisited and analysed for primary and secondary variables', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Use of investigational device according to Instructions for Use (IfU)\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05441618', 'acronym': 'LYOPLACE', 'briefTitle': 'Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Retrospective, Single Center, Single Arm Post Market Clinical Follow-Up (PMCF) Study on the Performance and Safety of Lyoplant® Used for the Replacement and Extension of Connective Tissue Structures in Neurosurgery', 'orgStudyIdInfo': {'id': 'AAG-O-H-2112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lyoplant®', 'description': 'Lyoplant® is a pure collagen implant obtained from bovine pericardium. The membrane is used for the replacement and extension of connective tissue structures in neurosurgery.', 'interventionNames': ['Device: Lyoplant®']}], 'interventions': [{'name': 'Lyoplant®', 'type': 'DEVICE', 'description': 'replacement and extension of connective tissue structures in neurosurgery', 'armGroupLabels': ['Lyoplant®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Augsburg AöR', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}], 'overallOfficials': [{'name': 'Philipp E Krauss, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Augsburg AöR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}