Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
Recruiting
N/A
Interventional Study
Intraventricular Hemorrhage (IVH)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 17 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Other
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About This Trial
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 pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts