Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03566602
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of wound infection confirmed by increase of CRP and positive cultures', 'timeFrame': 'up to 30 days after surgery', 'description': 'wound infection confirmed by increase of CRP and positive cultures'}, {'measure': 'Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)', 'timeFrame': 'intra-operative', 'description': 'intra-operative CSF leakage'}, {'measure': 'Incidence of percutaneous CSF leak confirmed by β-2 transferrin test', 'timeFrame': 'up to 30 days after surgery', 'description': 'Percutaneous CSF leak confirmed by β-2 transferrin test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrospinal Fluid Leak']}, 'referencesModule': {'references': [{'pmid': '34321304', 'type': 'DERIVED', 'citation': 'Van Doormaal T, Germans MR, Sie M, Brouwers B, Carlson A, Dankbaar JW, Fierstra J, Depauw P, Robe P, Regli L. Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial. BMJ Open. 2021 Jul 28;11(7):e049098. doi: 10.1136/bmjopen-2021-049098.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPreoperative Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.\n\nSubjects who are ≥ 18 years old. Subjects who are able to comply with the follow-up or other study requirements. Subjects who are planned for an elective intracranial intradural surgery in whom a dural incision of at least 2 cm in length is necessary, which will be closed.\n\nFemale subjects of child bearing potential must agree to use any form of contraception from the time of signing the informed consent form through 90 days post-surgery.\n\nIntraoperative Surgical wound classification Class I/Clean. Minimally 5 mm of dural space surrounding dural opening.\n\nExclusion Criteria:\n\nPreoperative Female subjects who are pregnant or breastfeeding. Subjects with an assumed impaired coagulation due to medication or otherwise. Subjects suspected of an infection requiring antibiotics. Subjects with any type of dural diseases in planned dural closure area. Subjects requiring re-opening of planned surgical area within 90 days after surgery.\n\nSubjects requiring local radiotherapy in planned surgical area. Subjects with a known allergy to any of the components of the Dura Sealant Patch.\n\nSubject who previously participated in this study or any investigational drug or device study within 30 days of screening.\n\nSubjects with a presence of hydrocephalus. Intraoperative Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Subjects who will require a CSF or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.\n\nPrimary closure of the dura mater with synthetic, non-autologous or autologous material other than galea.\n\nA gap \\> 3 mm after primary closure of the dura mater.'}, 'identificationModule': {'nctId': 'NCT03566602', 'briefTitle': 'Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Polyganics BV'}, 'officialTitle': 'Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery', 'orgStudyIdInfo': {'id': 'CIP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dura Sealant Patch', 'description': 'Application of Dura Sealant Patch after closure of the dura mater', 'interventionNames': ['Device: Dura Sealant Patch']}], 'interventions': [{'name': 'Dura Sealant Patch', 'type': 'DEVICE', 'description': 'Adjunctive bioresorbable patch', 'armGroupLabels': ['Dura Sealant Patch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Elisabeth TweeSteden Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMCU', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polyganics BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}