[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621474":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":27,"interventions":27,"overallOfficials":27,"centralContacts":33,"locations":43,"responsibleParty":82,"collaborators":84,"id":87,"slug":27,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":27,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":27,"enrollmentInfo":95,"targetDuration":27,"studyType":98,"phases":27,"briefSummary":99,"conditions":100,"keywords":27,"overallStatus":102,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Collagen Matrix","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of Revision Surgery","Rate of adverse events related to the Subject Device requiring surgical intervention.","at least one timepoint at 8 months or more post-surgery",[14,17,20,24],{"measure":15,"description":16,"timeFrame":12},"Rate of Adverse Events","Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele)",{"measure":18,"description":19,"timeFrame":12},"Product Performance","Score of adequacy of product performance - 1 (poor) to 4 (excellent)",{"measure":21,"description":22,"timeFrame":23},"Product Handling at Implantation","Score for product handling at implantation - 1 (poor) to 4 (excellent)","Initial surgery",{"measure":25,"description":26,"timeFrame":23},"Product Adaptability at Implantation","Score for product adaptability at implantation - 1 (poor) to 4 (excellent)",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.","All patients with a dural defect requiring repair with a dural substitute.",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":27,"email":38},"Meenakshi Paliwal","CONTACT","347-439-1634","mpaliwal@regenity.com",{"name":40,"role":36,"phone":41,"phoneExt":27,"email":42},"Sarah Grace Dennis-Little, PhD","706-247-0251","sgdennislittle@regenity.com",[44,65],{"facility":45,"status":27,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Rush University Medical Center","Chicago","Illinois","60612","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-87.65005,41.85003,{"lat":55,"lon":54},[58,62],{"name":59,"role":36,"phone":60,"phoneExt":27,"email":61},"Morgan Roll","312.563.6827","Morgan_L_Roll@rush.edu",{"name":63,"role":64,"phone":27,"phoneExt":27,"email":27},"Stephan Munich, MD","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":27,"city":67,"state":68,"zip":69,"country":49,"countryCode":50,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":52,"coordinates":71},[72,73],-71.05977,42.35843,{"lat":73,"lon":72},[76,80],{"name":77,"role":36,"phone":78,"phoneExt":27,"email":79},"Erica Fox","617-724-5805","efox15@mgh.harvard.edu",{"name":81,"role":64,"phone":27,"phoneExt":27,"email":27},"Brian Nahed, MD",{"type":83,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[85],{"name":86,"class":6},"Stryker Nordic","100621474",false,"NCT07371091","Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)","Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase","Inclusion Criteria:\n\n* Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice\n* Patient is 18 years or older\n* Patient of child-bearing potential is not pregnant or nursing\n* Participant is willing and able to provide consent\n\nExclusion Criteria:\n\n* Patients with a known history of hypersensitivity to bovine derived materials\n* Patients that are non-English speaking\n* Patients requiring legal representation","ALL","18 Years",{"count":96,"type":97},110,"ESTIMATED","OBSERVATIONAL","Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.",[101],"Repair of Dura Mater","NOT_YET_RECRUITING","2026-05-27",{"date":105,"type":106},"2026-05-29","ACTUAL",{"date":108,"type":97},"2026-07",{"date":110,"type":97},"2027-12",{"name":5,"class":6},2]