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Clinical Trial Summary

The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process. The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. 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 new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06382675
Study type Interventional
Source Fresenius Medical Care Deutschland GmbH
Contact Manuela Stauss-Grabo, Dr.
Phone +49 1525 469 1929
Email Manuela.Stauss-Grabo1@freseniusmedicalcare.com
Status Not yet recruiting
Phase N/A
Start date April 2024
Completion date March 2025

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