Trials / Completed
CompletedNCT03607825
FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Minnetronix · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to further demonstrate safety and characterize effectiveness of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following aneurysmal subarachnoid hemorrhage (aSAH).
Detailed description
The PILLAR-XT study is designed to further confirm safety and characterize efficacy of Neurapheresis therapy. The study works in tandem with the current SOC treatments for SAH and does not detract from the established care pathways, or deny enrolled subjects proven therapies. The PILLAR-XT study utilizes the established skill sets of chosen Investigators who are already trained in the treatment and care of SAH patients and insertion/management of lumbar drains.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Neurapheresis System | CSF filtration system and lumbar catheter |
Timeline
- Start date
- 2018-12-25
- Primary completion
- 2021-01-11
- Completion
- 2021-02-17
- First posted
- 2018-07-31
- Last updated
- 2022-10-06
- Results posted
- 2022-10-06
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03607825. Inclusion in this directory is not an endorsement.