11 Participants NeededMy employer runs this trial

Mechanical Tissue Resuscitation for Skull Defects

Recruiting at 2 trial locations
AM
Overseen ByAnna M Fryzel, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Renovo Concepts, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Mechanical Tissue Resuscitation™ (MTR®) to help remove excess fluid from individuals who have undergone partial skull removal, a procedure often necessary for brain healing. The trial aims to determine if MTR® can effectively and safely drain this fluid compared to traditional methods. Participants may qualify if they have had procedures such as craniotomy, craniectomy, or cranioplasty (types of skull surgeries) and require a drain during recovery.

As an unphased trial, this study provides participants the chance to contribute to pioneering research that could enhance recovery methods for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Mechanical Tissue Resuscitation™ (MTR®) therapy system is safe for fluid removal in skull defect cases?

Research has shown that Mechanical Tissue Resuscitation™ (MTR®) therapy is safe for humans. Studies have found that controlled suction can safely remove excess fluid from the brain. For instance, one study demonstrated that MTR could remove more than half of the fluid in cases of brain bleeding. Another study discovered that applying MTR immediately after an injury reduced brain swelling and preserved more brain tissue compared to those who did not receive the treatment. These findings suggest that MTR is well-tolerated and does not cause significant side effects.12345

Why are researchers excited about this trial?

Mechanical Tissue Resuscitation™ (MTR®) is unique because it represents a novel approach to treating skull defects, which are typically addressed with surgical interventions like bone grafts or synthetic implants. Unlike these traditional methods, MTR® uses a mechanical process to stimulate the body's natural healing mechanisms, potentially enhancing tissue regeneration without the need for invasive surgery. Researchers are excited about MTR® because it could reduce recovery times and lower the risks associated with surgical procedures, offering a less invasive and more efficient alternative for patients with skull defects.

What evidence suggests that the Mechanical Tissue Resuscitation™ (MTR®) therapy system is effective for skull defects?

Research has shown that Mechanical Tissue Resuscitation™ (MTR®), the treatment under study in this trial, might help treat conditions involving excess fluid in the brain. One study demonstrated that MTR® removed more than half of a brain bleed by applying controlled pressure. Another study found that using MTR® on brain injuries reduced swelling and preserved over 50% more brain tissue compared to untreated cases. These findings suggest that MTR® could help manage fluid-related brain issues and potentially improve outcomes for individuals with skull defects.13456

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 65 who need part of their skull removed (craniotomy/craniectomy) and would normally have a surgical drain placed. The surgery must be considered 'clean,' and participants must be able to give written consent.

Inclusion Criteria

I need brain surgery and will have a JP drain placed during the procedure.
I am between 22 and 65 years old.
My surgery is classified as clean with no infection or contamination.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive MTR® therapy for removal of excess fluid from the surgical site

7 days
Daily monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) approximately one month post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Mechanical Tissue Resuscitation™ (MTR®)

Trial Overview

The study is testing the Mechanical Tissue Resuscitation™ (MTR®) therapy system, a device designed to remove extra fluid after brain surgery in patients with part of their skull temporarily removed.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mechanical Tissue Resuscitation™ (MTR®)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Renovo Concepts, Inc.

Lead Sponsor

Trials
1
Recruited
9+

Boston Biomedical Associates

Lead Sponsor

Trials
9
Recruited
340+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37439483/

Novel treatment of intracerebral hemorrhage with ...

This study demonstrates that local continuous application of controlled subatmospheric pressure to an ICH can safely remove more than half ...

Novel treatment of intracerebral hemorrhage with ...

When ICHs were treated with MTR for 2 weeks, the gross hematomas were reduced by 94%, from 112.23 ± 66.21 mm ³ in the nontreated group to 6.12 ± 10.99 mm ³ in ...

Mechanical Tissue Resuscitation Technology Shows Promise ...

Brains treated with the device showed that over 50% more brain tissue could be preserved compared to nontreated animals. Behavioral function ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24618796/

Mechanical tissue resuscitation at the site of traumatic ...

Application of -100 mm Hg for 5 days resulted in significantly improved outcomes. Delays of up to 3 hours between injury and the initiation of treatment did not ...

Cardiopulmonary Resuscitation-Related Head Trauma

Introduction: In all cases of cardiac arrest, adequate cardiopulmonary resuscitation (CPR) performance is crucial for survival.

Mechanical Tissue Resuscitation treatment reduces injured ...

Our previous studies showed Mechanical Tissue Resuscitation. (MTR) treatment right after injury (<1 hour) reduces brain edema and extent of injury, and ...