Trials / Completed
CompletedNCT05747274
SRDK0921_ Analytical Performance Study
Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic (IVD) Medical Device in Patients With Kidney Transplant.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 439 (actual)
- Sponsor
- BioMAdvanced Diagnostics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
Detailed description
It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection. The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD). The SRDK0921 system (kit and software) is intended: * to calculate a score of subclinical rejection in kidney transplant patients * as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2023-09-29
- Completion
- 2023-09-29
- First posted
- 2023-02-28
- Last updated
- 2023-11-09
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05747274. Inclusion in this directory is not an endorsement.