Status:
RECRUITING
Intraventricular Catheter System for IVH
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
IRRAS
Conditions:
Intraventricular Hemorrhage (IVH)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressur...
Detailed Description
Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life- threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic stroke and i...
Eligibility Criteria
Inclusion
- Age \>=18 years of age
- Intraventricular hemorrhage documented on head CT or MRI scan
- Need of cerebrospinal fluid drainage
- Indication for active treatment evaluated by the treating physicians
- Signed informed consent obtained by patient or Legal Authorized Representative
- Treatment possible within 72 hours of ictus
Exclusion
- Patient has fixed and dilated pupils
- Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05970549
Start Date
June 14 2022
End Date
December 1 2025
Last Update
October 18 2024
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10128