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Procedure

IRRAflow® Catheter System for Intraventricular Hemorrhage (DIVE Trial)

N/A
Recruiting
Led By Christopher P Kellner, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >=18 years of age
Need of cerebrospinal fluid drainage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours post-procedure
Awards & highlights

DIVE Trial Summary

This trial will compare an FDA-approved catheter (IRRAflow®) to standard catheters for draining brain fluid to reduce pressure. Safety and outcomes will be evaluated.

Who is the study for?
This trial is for adults over 18 with a type of stroke that causes bleeding inside the brain's ventricles and requires fluid drainage. They must be able to start treatment within 72 hours of their stroke. Pregnant or nursing women, or those with fixed and dilated pupils, cannot participate.Check my eligibility
What is being tested?
The study compares the IRRAflow® Active Fluid Exchange System, which is FDA approved, to traditional drains in managing intracranial pressure after an intraventricular hemorrhage. Participants will also undergo non-contrast head CT scans as part of the evaluation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, infection risk due to invasive procedure, possible malfunction of device leading to inadequate drainage or over-drainage of cerebrospinal fluid.

DIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I need a procedure to drain fluid from my brain.

DIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Residual blood volume
Secondary outcome measures
Direct hospitalization costs
Hospital quality metrics
Length of stay in the NSICU
+1 more

DIVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IRRAflow with Active Fluid Exchange armExperimental Treatment2 Interventions
The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.
Group II: Retrospective analysis of traditional external ventricular drainsActive Control1 Intervention
The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,618 Total Patients Enrolled
IRRASIndustry Sponsor
3 Previous Clinical Trials
358 Total Patients Enrolled
Christopher P Kellner, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
416 Total Patients Enrolled

Media Library

IRRAflow® Active Fluid Exchange System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05970549 — N/A
Intraventricular Hemorrhage Research Study Groups: IRRAflow with Active Fluid Exchange arm, Retrospective analysis of traditional external ventricular drains
Intraventricular Hemorrhage Clinical Trial 2023: IRRAflow® Active Fluid Exchange System Highlights & Side Effects. Trial Name: NCT05970549 — N/A
IRRAflow® Active Fluid Exchange System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05970549 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is IRRAflow with Active Fluid Exchange arm a safe option for patients?

"As this is an early-phase trial, with limited information regarding safety and efficacy, IRRAflow with Active Fluid Exchange arm was given a score of 1."

Answered by AI

How many volunteers are engaged in this experiment?

"Affirmative. According to clinicaltrials.gov, the recruitment for this investigation is ongoing and commenced on June 14th 2022; it was last updated on July 24th 2023. They require 120 participants from a single medical centre."

Answered by AI

Is this research actively looking for participants?

"Indeed, information hosted on clinicaltrials.gov alludes to the fact that this trial is actively seeking participants. On June 14th 2022 it was introduced and most recently revised on July 24th 2023. Currently, 120 individuals are being sought from one site of enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intraventricular Catheter System for IVH
Christopher P Kellner 2022. "Intraventricular Catheter System for IVH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05970549.
~4 spots leftby Dec 2025
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