Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272084
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-02-05
Brief Title:
Analysis of TPE Treatments with MultiFiltratePRO
Sponsor:
Fresenius Medical Care Deutschland GmbH
Organization:
Fresenius Medical Care Deutschland GmbH
Study Overview
Official Title:
Analysis of TPE Treatments with MultiFiltratePRO
Status:
RECRUITING
Status Verified Date:
2024-09
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:
TPEopt
Brief 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
Detailed 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
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 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