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SRDK0921_ Analytical Performance Study

NCT05747274 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 439

Last updated 2023-11-09

No results posted yet for this study

Summary

Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)

Conditions

  • Kidney Transplant Rejection

Interventions

DEVICE

SRDK0921

SRDK0921 is an IVD composed of IVD kit for qPCR (SRDK0921KIT) and a cloud-based software (SRDK0921SOFT). It is a class C, rule 3k, IVD according to Regulation (EU) 2017/746.

Sponsors & Collaborators

  • Nantes University Hospital

    collaborator OTHER

  • BioMAdvanced Diagnostics

    lead INDUSTRY

Principal Investigators

  • Nicolas Bouler · BioMAdvanced Diagnostics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2023-09-29
Completion
2023-09-29

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 NCT05747274 on ClinicalTrials.gov