Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-27 @ 8:43 AM
Study NCT ID:
NCT02678156
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Performance of LYoplant® ONlay for Duraplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of re-operation because of Cerebrospinal Fluid leakage', 'timeFrame': 'until discharge (approximately 1 week)'}], 'secondaryOutcomes': [{'measure': 'Incidence of re-operation because of Cerebrospinal Fluid leakage', 'timeFrame': 'until follow-up (4 ± 2 months)'}, {'measure': 'Incidence of post operative complications', 'timeFrame': 'until discharge (approximately 1 week, 4±2 months)', 'description': 'Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others'}, {'measure': 'Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage', 'timeFrame': 'until discharge (approximately 1 week, 4±2 months)', 'description': 'detected during routine post operative MRI / CT examinations'}, {'measure': 'Intraoperative handling of the device', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed:\n\n* Ease of cutting\n* Needle penetration\n* Adaptation to the tissue\n* Suture retention strength\n* Onlay effect\n* Quality of sealing\n* Thickness\n* Tensile strength\n* Overall satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dura mater substitute', 'Graft', 'Lyoplant', 'Lyostypt', 'Lyoplant onlay', 'Xenograft'], 'conditions': ['Craniotomy', 'Duraplasty', 'Spinal Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay\n* Written informed consent\n* Life expectancy \\> 6 months\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Active local or systemic infections\n* Open cranial trauma\n* Open spina bifida\n* Known hypersensitivity to proteins of bovine origin\n* Representation by a legal guardian or under involuntary commitment\n* Pregnancy\n* Participation in another clinical study\n* Known primary immunodeficiency'}, 'identificationModule': {'nctId': 'NCT02678156', 'acronym': 'LYON', 'briefTitle': 'Assessment of the Performance of LYoplant® ONlay for Duraplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.', 'orgStudyIdInfo': {'id': 'AAG-O-H-1403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LYoplant ONlay', 'description': 'Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.', 'interventionNames': ['Device: Lyoplant Onlay']}], 'interventions': [{'name': 'Lyoplant Onlay', 'type': 'DEVICE', 'armGroupLabels': ['LYoplant ONlay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Klinikum Darmstadt', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Klinik für Neurochirurgie'}, {'zip': '55743', 'city': 'Idar-Oberstein', 'country': 'Germany', 'facility': 'Klinikum Idar-Oberstein', 'geoPoint': {'lat': 49.71443, 'lon': 7.30776}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}