Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649097
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYSTAL
Brief Summary:
The study is a multi-center prospective cohort controlled phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow Active Fluid Exchange System compared to standard of care external ventricular drains
Detailed Description:
The IRRAflow system offers automated irrigation controlled drainage and ICP monitoring all in one system for the treatment of intracranial hemorrhage - Intracerebral hemorrhage ICH Intraventricular hemorrhage IVH Subarachnoid hemorrhage SAH Subdural hematoma SDH intracranial abscess and ventriculitis
The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care Such treatment includes but is not limited to neurointensive care neuromonitoring and surgical or endovascular occlusion of identified sources of intracranial hemorrhage eg vascular anomalies aneurysms etc
The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care Such treatment includes but is not limited to neurointensive care neuromonitoring and surgical or endovascular occlusion of identified sources of intracranial hemorrhage eg vascular anomalies aneurysms etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None