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Clinical Trial Summary

Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.


Clinical Trial Description

The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the TPE mode of the multiFiltratePRO system. The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06272084
Study type Observational
Source Fresenius Medical Care Deutschland GmbH
Contact Manuela Stauss-Grabo, Dr.
Phone +4915254601929
Email Manuela.Stauss-Grabo1@freseniusmedicalcare.com
Status Not yet recruiting
Phase
Start date May 2024
Completion date December 2024

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