Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-01 @ 3:56 AM
Study NCT ID:
NCT06580405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
Sponsor:
Kaneka Medical America LLC
Organization:
Study Overview
Official Title:
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
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:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: