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New Brain-Cleaning catheter could speed recovery after stroke

NCT ID NCT05970549

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a special catheter called IRRAflow that both drains fluid and actively irrigates the brain to remove blood after a hemorrhage. The trial will compare this device to standard catheters in 17 adults with intraventricular hemorrhage. Researchers want to see if it reduces leftover blood and improves hospital outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IRRAflow® Active Fluid Exchange System (a special catheter that irrigates and drains fluid from the brain)
What this could lead to
If it works, this could offer a safer and more effective way to remove blood from the brain after a hemorrhage, potentially leading to better recovery and shorter hospital stays.
What could go wrong
This is a very small early-stage study with only 17 participants, so results may not apply to everyone. The device is already FDA-approved, but its advantage over standard catheters is unproven, and there are always risks with brain procedures like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 17 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Treatment possible within 72 hours of ictus Exclusion Criteria: * 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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intraventricular hemorrhage (IVH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10128, United States

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