Trials / Recruiting
RecruitingNCT06272084
Analysis of TPE Treatments With multiFiltratePRO
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- Fresenius Medical Care Deutschland GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO | Retrospective Data Analysis of TPE treatments with multiFiltratePRO |
Timeline
- Start date
- 2024-05-22
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2024-02-22
- Last updated
- 2025-08-28
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06272084. Inclusion in this directory is not an endorsement.