[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556801":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":33,"locations":39,"responsibleParty":196,"collaborators":198,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":203,"sex":209,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":26,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},{"fullName":5,"class":6},"Auxilium Biotechnologies","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"NeuroGen Nerve Guide","ACTIVE_COMPARATOR","The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.",[13,14],"Device: NeuroSpan Bridge","Device: NeuroGen Nerve Guide",{"label":16,"type":10,"description":17,"interventionNames":18},"Nerve Autograft","The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.",[13,19],"Device: Nerve Autograft",[21,27,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","NeuroSpan Bridge","The implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap.\n\nThe NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve stump.",[16,9],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"The NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth Factor.",[9],{"type":22,"name":16,"description":31,"armGroupLabels":32,"otherNames":26},"A nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap",[16],[34],{"name":35,"role":36,"phone":37,"phoneExt":26,"email":38},"Jacob Koffler, PhD, MBA","CONTACT","858-699-9443","j.koffler@auxiliumbio.com",[40,65,84,104,120,140,160,177],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"UC San Diego Health","RECRUITING","San Diego","California","92103","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-117.16472,32.71571,{"lat":52,"lon":51},[55,59,62],{"name":56,"role":36,"phone":57,"phoneExt":26,"email":58},"Dominic Baun","858-534-8268","jbaun@health.ucsd.edu",{"name":60,"role":36,"phone":26,"phoneExt":26,"email":61},"Abigail Yap","abyap@health.ucsd.edu",{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Reid Abrams, MD","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":42,"city":67,"state":44,"zip":68,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"UCSF Orthopedic Institute","San Francisco","94158",{"type":49,"coordinates":70},[71,72],-122.41942,37.77493,{"lat":72,"lon":71},[75,79,82],{"name":76,"role":36,"phone":77,"phoneExt":26,"email":78},"Aamna Haq","415-514-8707","aamna.haq@ucsf.edu",{"name":80,"role":36,"phone":26,"phoneExt":26,"email":81},"Jillene Sturgess-Daprato","Jillene.Sturgess@ucsf.edu",{"name":83,"role":64,"phone":26,"phoneExt":26,"email":26},"Igor Immerman, M.D.",{"facility":85,"status":42,"city":86,"state":87,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Medstar Union Memorial Hospital- The Curtis National Hand Center","Baltimore","Maryland","21218",{"type":49,"coordinates":90},[91,92],-76.61219,39.29038,{"lat":92,"lon":91},[95,99,102],{"name":96,"role":36,"phone":97,"phoneExt":26,"email":98},"Ike Fleming","410-554-2486","Ike.C.Fleming@Medstar.net",{"name":100,"role":36,"phone":26,"phoneExt":26,"email":101},"Carly Kingston","Carly.Q.Kingston@medstar.net",{"name":103,"role":64,"phone":26,"phoneExt":26,"email":26},"Aviram Giladi",{"facility":105,"status":42,"city":106,"state":106,"zip":107,"country":46,"countryCode":47,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"NYU Langone Orthopedic Center","New York","10003",{"type":49,"coordinates":109},[110,111],-74.00597,40.71427,{"lat":111,"lon":110},[114,118],{"name":115,"role":36,"phone":116,"phoneExt":26,"email":117},"Ann Hu","646-501-2180","Ann.Hu@nyulangone.org",{"name":119,"role":64,"phone":26,"phoneExt":26,"email":26},"Jaques Hacquebord, M.D.",{"facility":121,"status":42,"city":122,"state":123,"zip":124,"country":46,"countryCode":47,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"OSU Wexner Medical Center","Columbus","Ohio","43212",{"type":49,"coordinates":126},[127,128],-82.99879,39.96118,{"lat":128,"lon":127},[131,135,138],{"name":132,"role":36,"phone":133,"phoneExt":26,"email":134},"Emily Rice","614-293-5871","Emily.Rice2@osumc.edu",{"name":136,"role":36,"phone":26,"phoneExt":26,"email":137},"Irene Kaptsan","Irina.Kaptsan@osumc.edu",{"name":139,"role":64,"phone":26,"phoneExt":26,"email":26},"Amy Moore, M.D.",{"facility":141,"status":42,"city":142,"state":143,"zip":144,"country":46,"countryCode":47,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"University of Pennsylvania- Penn Presbyterian Medical Center","Philadelphia","Pennsylvania","19104",{"type":49,"coordinates":146},[147,148],-75.16362,39.95238,{"lat":148,"lon":147},[151,155,158],{"name":152,"role":36,"phone":153,"phoneExt":26,"email":154},"Ellen Stinger","215-273-5064","Ellen.Stinger@Pennmedicine.upenn.edu",{"name":156,"role":36,"phone":26,"phoneExt":26,"email":157},"Annamarie Horan","HoranA@pennmedicine.upenn.edu",{"name":159,"role":64,"phone":26,"phoneExt":26,"email":26},"David Bozentka, M.D.",{"facility":161,"status":42,"city":162,"state":163,"zip":164,"country":46,"countryCode":47,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"UT Health Houston","Houston","Texas","77030",{"type":49,"coordinates":166},[167,168],-95.36327,29.76328,{"lat":168,"lon":167},[171,175],{"name":172,"role":36,"phone":173,"phoneExt":26,"email":174},"Tien Do","281-857-2353","Tien.Do@uth.tmc.edu",{"name":176,"role":64,"phone":26,"phoneExt":26,"email":26},"Jeffrey Trost, MD",{"facility":178,"status":42,"city":179,"state":163,"zip":180,"country":46,"countryCode":47,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"The San Antonio Orthopaedic Group (TSAOG Orthopaedics)","San Antonio","78258",{"type":49,"coordinates":182},[183,184],-98.49363,29.42412,{"lat":184,"lon":183},[187,191,194],{"name":188,"role":36,"phone":189,"phoneExt":26,"email":190},"Amanda Strickland","509-951-1382","astrickland@tsaog.com",{"name":192,"role":36,"phone":26,"phoneExt":26,"email":193},"Monica Contreras","mcontreras@tsaog.com",{"name":195,"role":64,"phone":26,"phoneExt":26,"email":26},"Mickey Cho, M.D.",{"type":197,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[199],{"name":200,"class":6},"MCRA","100556801","a-comparison-of-neurospan-bridge-neuragen-nerve-guide-and-nerve-autograft-for-peripheral-nerve-repair-100556801",false,"NCT06529835","A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair","A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)","NeuroSpan-1","Inclusion Criteria:\n\n1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.\n2. Nerve diameter at injury site ≤3mm.\n3. Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.\n4. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm\n5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm\n6. Repair must take place within 3 months from injury\n7. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)\n\nExclusion Criteria:\n\n1. Previous history of nerve repair attempt at the treated nerve.\n2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.\n3. Allergy to Bovine products such as Bovine Collagen Nerve Cuff.\n4. Pregnancy or planning to become pregnant","ALL","18 Years","80 Years",{"count":213,"type":214},80,"ESTIMATED","INTERVENTIONAL",[217],"NA","This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.",[220],"Peripheral Nerve Injuries","2026-06-24",{"date":223,"type":224},"2026-06-26","ACTUAL",{"date":226,"type":224},"2025-03-21",{"date":228,"type":214},"2028-08",{"name":5,"class":6},8]