Trials / Not Yet Recruiting
Not Yet RecruitingNCT06580405
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- Sponsor
- Kaneka Medical America LLC · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | KNP-1000 Apheresis System | sFlt-1 is removed from the participants' plasma through treatment. |
Timeline
- Start date
- 2025-05-31
- Primary completion
- 2026-04-30
- Completion
- 2028-06-30
- First posted
- 2024-08-30
- Last updated
- 2025-03-05
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06580405. Inclusion in this directory is not an endorsement.