Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New brain fluid drain device tested in tiny trial

NCT ID NCT06201429

Disease control Sponsor: Renovo Concepts, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a device called Mechanical Tissue Resuscitation (MTR) that is designed to drain excess fluid from the brain area after a person has had part of their skull removed or repaired. The trial will include 11 people who need a drain as part of their standard care. The main goal is to see if the device is safe and can remove fluid without causing harm.

What this could mean

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

Active substance
Mechanical Tissue Resuscitation (MTR) therapy system (a device that drains excess fluid from the brain area after skull surgery)
What this could lead to
If it works, this could offer a safer, more effective way to remove fluid after skull surgery, potentially reducing complications.
What could go wrong
This is a very early feasibility study with only 11 people, so it is not designed to prove effectiveness. The device may not work as hoped or could cause side effects like tissue damage 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 11 people

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

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 to 65 years

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: Phase 1: 1. Patient is willing and able to provide written informed consent or has an appointed legally authorized representative (LAR) who can provide consent on the patient's behalf. 2. The patient's age is ≥ 22 and ≤ 65 years. 3. The patient has a clinical need for a craniotomy, craniectomy, or cranioplasty and for which, as an integral part of their care, a Jackson Pratt (JP) drain or equivalent would be placed at the surgical site. 4. The surgical case is classified as 'clean'. Phase 2: 1. All Phase 1 criteria 2. Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils. Phase 3: 1. All Phase 1 criteria 2. Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils. Exclusion Criteria: Phase 1: 1. Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13. 2. Patient is pregnant or lactating. 3. Patient's BMI \> 45 4. Patient is participating in another clinical investigation. 5. Patient's anticipated survival is \< 48 hours. 6. Patient is incarcerated at time of hospital admission. 7. Patient has a coincidental infection. 8. Patient has thrombocytopenia (platelet count \< 150,000/µL). 9. Patient has an International Normalized Ratio (INR) \> 1.5. 10. Patient is a known active opioid abuser at the time of surgery. 11. Patient is a known active alcohol abuser at the time of surgery. 12. Active bleeding at the site of surgery prior to placement of the device. Phases 2 and 3: 1\. Exclusion criteria 2-12 from Phase 1

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Clinical need for cranioplasty are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

traumatic brain injury

As listed by the trial registrant

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

Clinical need for cranioplasty Clinical need for craniotomy or craniectomy

How to take part

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

  1. The places running it

    3 sites. 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

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • University at Buffalo Neurosurgery

    RECRUITING

    Buffalo, New York, 14203, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.