[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579332":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":19,"studyPopulation":20,"armGroups":11,"interventions":11,"overallOfficials":11,"centralContacts":21,"locations":33,"responsibleParty":51,"collaborators":11,"id":53,"slug":11,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":11,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Collagen Matrix","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Measurement of the occurrence of adverse event requiring surgical intervention",null,"6-9 months",[14],{"measure":15,"description":11,"timeFrame":12},"Adverse events i.e., infection, CSF leak and Pseudomeningocele",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":17,"timePerspective":18,"maskingInfo":11},"OTHER","PROSPECTIVE","A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \\& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.","The subject device is intended for all patient populations. The following population is excluded from the study:-\n\n* Pregnant Women\n* Subjects requiring Legally Authorized Representative\n* Subjects under 18 years of age",[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Meenakshi Paliwal","CONTACT","2014051477","324","mpaliwal@regenity.com",{"name":29,"role":24,"phone":30,"phoneExt":31,"email":32},"Peggy Hansen","201-405-1477","304","phansen@regenity.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Medical Collagen of Wisconsin","RECRUITING","Milwaukee","Wisconsin","53226","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-87.90647,43.0389,{"lat":46,"lon":45},[49],{"name":50,"role":24,"phone":11,"phoneExt":11,"email":11},"Kaitlin Goetschel",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100579332",false,"NCT06822920","Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)","Monitoring the Use of Collagen Dura Membrane in the Post-market Phase","DM&DMO","Inclusion Criteria:\n\n* Patients with a dural defect requiring repair with a dural substitute.\n\nExclusion Criteria:\n\n* There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.","ALL","18 Years",{"count":63,"type":64},110,"ESTIMATED","OBSERVATIONAL","Monitoring the Use of Collagen Dura Membrane in the Post-market phase",[68],"Repair of Dura Mater","2025-02-07",{"date":71,"type":72},"2025-02-12","ACTUAL",{"date":74,"type":72},"2025-01-03",{"date":76,"type":64},"2025-12-30",{"name":5,"class":6},1]