[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506753":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":112,"collaborators":20,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":20,"enrollmentInfo":124,"targetDuration":20,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Vitestro B.V.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autonomous blood drawing","EXPERIMENTAL","Hospital Sites (outpatients visiting blood drawing department):\n\nIn study Phase A1, B1, B2, C1, a subject visiting the outpatient blood drawing department will receive one automated blood draw with the Venipuncture Device. This blood draw is additional to the manual blood draw.\n\nIn study Phase C2 and Phase C3 the automated blood draw replaces the manual blood draw. In both Phases, the subject might therefore receive two automated blood draws, in case a redraw is required. In study Phase B3, the automated blood draw also replaces the manual blood draw. The subject will receive two automated blood draws.\n\nVitestro Site (volunteers):\n\nIn study Phase A, C1 volunteers visit Vitestro Site. Participants receive one to two automated blood draws.",[13],"Device: Venipuncture Device (VD)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Venipuncture Device (VD)","The Venipuncture Device is a pre-market medical device that fully automates the blood drawing procedure (also called phlebotomy or venipuncture). It automatically detects a vein using near-infrared and ultrasound imaging technology, robotically inserts a needle, automatically connects blood tubes and applies pressure to the puncture site.\n\nDuring the ADOPT Study, the technology is further improved over time; for example features are released (such as: automated tourniquet). Initially, several manual steps are required to be performed by a device supervisor and operator. At the final stage of the ADOPT Study, Phase C2 and Phase C3, the device has full functionality and only limited manual steps are required to be performed by a device supervisor.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Luuk Giesen, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+31 30 200 45 51","luuk.giesen@vitestro.com",{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},"Jeroen Roest, MSc","jeroen.roest@vitestro.com",[34,54,67,83,99],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"OLVG Lab","RECRUITING","Amsterdam","North Holland","1091 AC","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],4.88969,52.37403,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":20,"email":52},"Martine Deckers, PhD","+31 20 510 89 51","m.deckers@olvg.nl",{"name":50,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":55,"status":36,"city":37,"state":38,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Amsterdam UMC","1105 AZ",{"type":43,"coordinates":58},[45,46],{"lat":46,"lon":45},[61,65],{"name":62,"role":27,"phone":63,"phoneExt":20,"email":64},"Robert de Jonge, prof. dr.","+31 20 566 4851","r.dejonge1@amsterdamumc.nl",{"name":66,"role":24,"phone":20,"phoneExt":20,"email":20},"Robert de Jonge, prof. PhD",{"facility":68,"status":36,"city":69,"state":70,"zip":71,"country":40,"countryCode":41,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Result Laboratorium, location Albert Schweitzer Hospital","Dordrecht","South Holland","3318 AT",{"type":43,"coordinates":73},[74,75],4.67361,51.81,{"lat":75,"lon":74},[78,82],{"name":79,"role":27,"phone":80,"phoneExt":20,"email":81},"Michael Fouraux, PhD","+31 78 654 1810","m.fouraux@resultlaboratorium.nl",{"name":79,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":84,"status":36,"city":85,"state":86,"zip":87,"country":40,"countryCode":41,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"St. Antonius Hospital","Nieuwegein","Utrecht","3435CM",{"type":43,"coordinates":89},[90,91],5.08056,52.02917,{"lat":91,"lon":90},[94,98],{"name":95,"role":27,"phone":96,"phoneExt":20,"email":97},"Thijs van Holten, PhD","+31 88 320 7190","t.van.holten@antoniusziekenhuis.nl",{"name":95,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":100,"status":101,"city":86,"state":86,"zip":102,"country":40,"countryCode":41,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Vitestro","NOT_YET_RECRUITING","3526KS",{"type":43,"coordinates":104},[105,106],5.12222,52.09083,{"lat":106,"lon":105},[109,111],{"name":23,"role":27,"phone":110,"phoneExt":20,"email":29},"+31 30 200 4551",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":113,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100506753","autonomous-blood-drawing-optimization-and-performance-testing-100506753",false,"NCT05878483","Autonomous Blood Drawing Optimization and Performance Testing","ADOPT","Inclusion Criteria:\n\n• Age ≥16 years.\n\nExclusion Criteria:\n\n* Unable to follow instructions, due to mental disability and\u002For incapacity\n* Unable to use device correctly due to physical impairment or disability (for example a patient with severe contractures or deformities)\n* No venipuncture possible in cubital fossa of both arms (for example: after amputation of both arms)\n* No venipuncture possible in cubital fossa due to contra-indications in both arms (for example: tattoos in both arms)\n* Incapacitated persons\n* Pregnant or breast-feeding\n\nThe following contra-indications \u002F exclusion criteria are respected per arm:\n\n* Arteriovenous fistula or vascular graft\n* Paretic or paralyzed arm (e.g. after stroke or trauma)\n* Infected skin in cubital fossa (for example: erysipelas or cellulitis)\n* Mastectomy side, axillary lymph node excised\n* Healed skin burns in cubital fossa\n* Edema in cubital fossa\n* Extensive scarring in cubital fossa\n* Hematoma in cubital fossa\n* Tattoos in cubital fossa\n\nIn case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2 or B3, venipunctures are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 and Phase B3 study.",true,"ALL","16 Years",{"count":125,"type":126},44658,"ESTIMATED","INTERVENTIONAL",[129],"NA","The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device).\n\nThe study consists of several phases (A, B1, B2, C1, C2, C3, 0).\n\nPhase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing.\n\nPhases A, B2, B3, C1, C2, C3 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection).\n\nThe study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers can be included in a non-hospital site (Vitestro Site).",[132,133],"Venipuncture","Phlebotomy",[135,136,133,137],"Autonomous","Blood Drawing","Robotics","2026-04-01",{"date":140,"type":141},"2026-04-07","ACTUAL",{"date":143,"type":141},"2023-07-21",{"date":145,"type":126},"2029-12-31",{"name":5,"class":6},5]