New brain fluid drain device tested in tiny trial

NCT ID NCT06201429

Recruiting now Disease control Sponsor: Renovo Concepts, Inc. Source: ClinicalTrials.gov ↗

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.

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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

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

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