[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522416":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":21,"locations":26,"responsibleParty":59,"collaborators":21,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":21,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"MagIA Diagnostics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","This study is single arm.",[13,14],"Diagnostic Test: MagIA IBC test in capillary blood","Diagnostic Test: MagIA IBC test in other blood matrices",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","MagIA IBC test in capillary blood","After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"MagIA IBC test in other blood matrices","Blood samples will be taken and used to perform the MagIA IBC in veinous blood, serum and plasma, except for outdoor tested subjects",[9],[27,40],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":31,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":21},"Hopital Européen de Marseille","COMPLETED","Marseille","France","13003","FR",{"type":35,"coordinates":36},"Point",[37,38],5.38107,43.29695,{"lat":38,"lon":37},{"facility":41,"status":42,"city":43,"state":21,"zip":44,"country":31,"countryCode":33,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Centre Hospitalier de Perpignan - Equipe Mobile Hépatites","RECRUITING","Perpignan","66000",{"type":35,"coordinates":46},[47,48],2.89541,42.69764,{"lat":48,"lon":47},[51,56],{"name":52,"role":53,"phone":54,"phoneExt":21,"email":55},"REMY, Dr","CONTACT","04 68 61 68 14","andre.remy@ch-perpignan.fr",{"name":57,"role":58,"phone":21,"phoneExt":21,"email":21},"Andre-Jean REMY, Dr","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100522416","prospective-clinical-performance-evaluation-of-the-in-vitro-diagnostics-medical-device-magia-ibc-for-the-combined-screening-of-hiv-hepatitis-b-and-hepatitis-c-100522416",false,"NCT06082336","Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C","MAGICIEN","Inclusion Criteria:\n\nIC1. A Male or Female aged of at least 18 years\n\nIC2. A person responding to one of the following conditions:\n\n* known having HIV infection\n* or known having HBV infection\n* or known or suspected having HCV infection with anti-HCV RDT positive. IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance or being enrolled during an outdoor testing campaign.\n\nExclusion Criteria:\n\nEC1. A person for whom blood sampling would represent a risk, EC2. A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)",true,"MALE","18 Years",{"count":72,"type":73},252,"ESTIMATED","INTERVENTIONAL",[76],"NA","Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study.\n\nThe Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics).\n\nValidation Phase is between Sept. 2024 and still ongoing.",[79],"Combined Point of Care Diagnostic of HIV, HBV and HCV",[81,82,83,84],"point of care diagnostic","HIV","HCV","HBV","2026-01-30",{"date":87,"type":88},"2026-02-03","ACTUAL",{"date":90,"type":88},"2024-09-16",{"date":92,"type":73},"2026-11",{"name":5,"class":6},2]