[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577733":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":17,"interventions":23,"overallOfficials":17,"centralContacts":28,"locations":40,"responsibleParty":84,"collaborators":17,"id":86,"slug":17,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":17,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":17,"enrollmentInfo":94,"targetDuration":17,"studyType":97,"phases":17,"briefSummary":90,"conditions":98,"keywords":17,"overallStatus":43,"whyStopped":17,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Collagen Matrix","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of Revision Surgery","Adequate healing of dural defects without need for a revision surgery or second intervention","8 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Rate of Adverse events","Rate of product-related adverse events or complications",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.\n\nNo original patient records or personal identifying information will be disclosed to Collagen Matrix.","The general population will be included in the study where a dura substitute is required for the repair of dura mater",[24],{"type":25,"name":26,"description":27,"armGroupLabels":17,"otherNames":17},"OTHER","Post Market Study","Prospective case series without a concurrent comparator group.",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Meenakshi Paliwal","CONTACT","2014051477","324","mpaliwal@regenity.com",{"name":36,"role":31,"phone":37,"phoneExt":38,"email":39},"Peggy Hansen","201-405-1477","304","phansen@regenity.com",[41,65],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Augusta University","RECRUITING","Augusta","Georgia","30912","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-81.97484,33.47097,{"lat":53,"lon":52},[56,59,62],{"name":57,"role":31,"phone":17,"phoneExt":17,"email":58},"Candelario Laserna, MD","CALASERNA@augusta.edu",{"name":60,"role":31,"phone":17,"phoneExt":17,"email":61},"Natasha Flores","NFLORES@augusta.edu",{"name":63,"role":64,"phone":17,"phoneExt":17,"email":17},"Scott Rahimi, MD","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":43,"city":67,"state":68,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":50,"coordinates":71},[72,73],-71.05977,42.35843,{"lat":73,"lon":72},[76,79,82],{"name":77,"role":31,"phone":17,"phoneExt":17,"email":78},"Sophie A Munn","samunn@mgh.harvard.edu",{"name":80,"role":31,"phone":17,"phoneExt":17,"email":81},"Erica Fox","efox15@mgh.harvard.edu",{"name":83,"role":64,"phone":17,"phoneExt":17,"email":17},"Brian Nahed, MD",{"type":85,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100577733",false,"NCT06802133","Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)","Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.","Inclusion Criteria:\n\n* The general population will be included in the study where a dura substitute is required for the repair of dura mater.\n\nExclusion Criteria:\n\n* Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.","ALL","18 Years",{"count":95,"type":96},118,"ESTIMATED","OBSERVATIONAL",[99],"Repair of Dura Mater","2025-10-14",{"date":102,"type":103},"2025-10-15","ACTUAL",{"date":105,"type":103},"2025-01-13",{"date":107,"type":96},"2026-07-30",{"name":5,"class":6},2]