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Clinical Performance Study of Safety Test ABO Device

NCT06543771 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-09

No results posted yet for this study

Summary

The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.

Conditions

  • Transfusion Reaction

Interventions

DIAGNOSTIC_TEST

Safety Test ABO and ABTest Card®

Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).

Sponsors & Collaborators

  • Soladis

    collaborator INDUSTRY

  • Diagast

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06543771 on ClinicalTrials.gov