[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553894":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":7,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":7,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":7,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":72,"whyStopped":7,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Abbott Rapid Dx","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DIAGNOSTIC_TEST","Panbio™ HCV Self Test","Rapid diagnostic test (self-test and professional) plus laboratory reference tests",[14,15],"Fingerstick HIV testing (optional)","Laboratory reference testing for HCV (immunoassays and PCR, CE marked)",[17],{"name":18,"affiliation":19,"role":20},"Pablo Ryan, MD, PhD","Hospital Universitario Infanta Leonor","PRINCIPAL_INVESTIGATOR",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Camilla S Forssten, PhD","CONTACT","+447792902244","camilla.forssten@abbott.com",{"name":28,"role":24,"phone":29,"phoneExt":7,"email":30},"Jocelyn Farge, MSc, MBA","+33666483563","jocelyn.farge@abbott.com",[32],{"facility":33,"status":7,"city":34,"state":7,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hospital Universitario infanta Leonor","Madrid","28031","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-3.70256,40.4165,{"lat":42,"lon":41},[45,47],{"name":18,"role":24,"phone":7,"phoneExt":7,"email":46},"pablo.ryan@salud.madrid.org",{"name":48,"role":24,"phone":7,"phoneExt":7,"email":7},"Jorge Valencia, MD, PhD",{"type":50,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100553894","lay-user-evaluation-of-the-panbio-hcv-self-test-in-an-eu-population-100553894",false,"NCT06492018","Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population","Inclusion Criteria:\n\n* Participant is aged 18 or over\n* Participant agrees to all aspects of the study and is able and willing to provide informed consent \u002F assent with parental consent.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is deemed unfit for the study by the Investigator.\n* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.\n* Participant is a practising health-care professional or laboratory scientist \u002F technician or has prior medical or laboratory training or experience\n* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.\n* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.\n* Participant is unwilling or unable to provide informed consent.",true,"ALL","18 Years",{"count":61,"type":62},150,"ESTIMATED","OBSERVATIONAL","This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022\u002F1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017\u002F746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.",[66],"Hepatitis C",[68,69,70,71],"Rapid diagnostic test","Antibodies to Hepatitis C Virus (HCV).","Self-test","Lay user","NOT_YET_RECRUITING","2024-11-20",{"date":75,"type":76},"2024-11-22","ACTUAL",{"date":78,"type":62},"2024-12-01",{"date":80,"type":62},"2025-03-30",{"name":5,"class":6},1]