Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382675
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-22
Brief Title:
Clinical Performance of the New Plasma Filter PX2 in TPE Treatments
Sponsor:
Fresenius Medical Care Deutschland GmbH
Organization:
Fresenius Medical Care Deutschland GmbH
Study Overview
Official Title:
Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
plasmaFlux
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-23-11-044643 | OTHER | Unique identification number EUDAMED | None |