[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608968":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":26,"overallOfficials":13,"centralContacts":13,"locations":30,"responsibleParty":108,"collaborators":13,"id":110,"slug":13,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":13,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":13,"enrollmentInfo":118,"targetDuration":13,"studyType":121,"phases":122,"briefSummary":123,"conditions":124,"keywords":13,"overallStatus":33,"whyStopped":13,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Voll Medical Technologies Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Device-related Serious Adverse Events","Incidence of device-related serious adverse events (DRSAEs) related to the spacer.","Up to 12 months post-implantationץ",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":13,"interventionNames":24},"Voll Degradable Shoulder Spacer","EXPERIMENTAL",[25],"Device: Voll Degradable Shoulder Spacer",[27],{"type":28,"name":22,"description":22,"armGroupLabels":29,"otherNames":13},"DEVICE",[22],[31,55,71,91],{"facility":32,"status":33,"city":34,"state":13,"zip":13,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Assuta Ashdod Hospital","RECRUITING","Ashdod","Israel","IL",{"type":38,"coordinates":39},"Point",[40,41],34.64966,31.79213,{"lat":41,"lon":40},[44,49,52],{"name":45,"role":46,"phone":47,"phoneExt":13,"email":48},"Sahar Boostenay","CONTACT","+97254421243","sahar@vollmedical.com",{"name":50,"role":51,"phone":13,"phoneExt":13,"email":13},"Ran Atzmon, MD","PRINCIPAL_INVESTIGATOR",{"name":53,"role":54,"phone":13,"phoneExt":13,"email":13},"Yariv Goldstein, MD","SUB_INVESTIGATOR",{"facility":56,"status":57,"city":58,"state":13,"zip":13,"country":35,"countryCode":36,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Ichilov (Sourasky Medical Center)","NOT_YET_RECRUITING","Tel Aviv",{"type":38,"coordinates":60},[61,62],34.78057,32.08088,{"lat":62,"lon":61},[65,67,69],{"name":45,"role":46,"phone":66,"phoneExt":13,"email":48},"+972544621243",{"name":68,"role":51,"phone":13,"phoneExt":13,"email":13},"Efi Kazum, MD",{"name":70,"role":54,"phone":13,"phoneExt":13,"email":13},"Eran Maman, MD",{"facility":72,"status":57,"city":73,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Humanitas Gavazzeni Castelli","Bergamo","24125","Italy","IT",{"type":38,"coordinates":78},[79,80],9.66721,45.69601,{"lat":80,"lon":79},[83,85,87,89],{"name":45,"role":46,"phone":66,"phoneExt":13,"email":84},"saharb@vollmedical.com",{"name":86,"role":51,"phone":13,"phoneExt":13,"email":13},"Vincenzo Condello, MD",{"name":88,"role":54,"phone":13,"phoneExt":13,"email":13},"Vincenzo Madonna, MD",{"name":90,"role":54,"phone":13,"phoneExt":13,"email":13},"Marco Collarile, MD",{"facility":92,"status":33,"city":93,"state":93,"zip":94,"country":75,"countryCode":76,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Istituto Ortopedico Rizzoli","Bologna","40136",{"type":38,"coordinates":96},[97,98],11.33875,44.49381,{"lat":98,"lon":97},[101,102,104,106],{"name":45,"role":46,"phone":66,"phoneExt":13,"email":84},{"name":103,"role":51,"phone":13,"phoneExt":13,"email":13},"Stefano Zaffagnini, Prof.",{"name":105,"role":54,"phone":13,"phoneExt":13,"email":13},"Federico Coliva, MD",{"name":107,"role":54,"phone":13,"phoneExt":13,"email":13},"Vitogaetano Rinaldi, MD",{"type":109,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100608968",false,"NCT07208448","Voll Degradable Shoulder Spacer FIH Study","A Multi-Center, Prospective, First-In-Human Study to Evaluate the Initial Safety and Effectiveness of a Degradable Shoulder Spacer in Patients With Symptomatic Massive Rotator Cuff Tears","Main Inclusion Criteria:\n\n* Full thickness MRCT.\n* Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits.\n\nMain Exclusion Criteria:\n\n* Documented evidence of a history of drug\u002Falcohol abuse within 1 year of enrollment.\n* Concurrent participation in any other investigational clinical study.","ALL","50 Years",{"count":119,"type":120},20,"ESTIMATED","INTERVENTIONAL",[15],"The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).",[125],"Massive Rotator Cuff Tear","2026-03-05",{"date":128,"type":129},"2026-03-06","ACTUAL",{"date":131,"type":129},"2025-12-09",{"date":133,"type":120},"2027-12-31",{"name":5,"class":6},4]