Status:
UNKNOWN
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Lead Sponsor:
MagIA Diagnostics
Conditions:
Combined Point of Care Diagnostic of HIV, HBV and HCV
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- IC1. A Male or Female aged of at least 18 years
- IC2. A person taken care at Hôpital Européen de Marseille and responding to at least one of the following conditions:
- known or suspected having HIV infection
- known or suspected having HBV infection
- known or suspected having or having had HCV infection IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance.
Exclusion
- EC1. 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)
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06082336
Start Date
January 23 2023
End Date
September 30 2024
Last Update
October 13 2023
Active Locations (1)
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1
Hopital Européen de Marseille
Marseille, France, 13003