Mechanical Tissue Resuscitation (MTR) drainage after skull surgery

A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.

This trial will try the Mechanical Tissue Resuscitation (MTR) device to drain excess fluid in adults 22–65 who have had part of their skull removed and need surgical drainage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 11 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: Renovo Concepts, Inc. (Industry-sponsored)
• Locations: 3 sites (Buffalo, New York and 2 other locations)
• Trial ID: NCT06201429 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multi-center early-feasibility trial testing the MTR device to externally drain excess fluid from craniotomy, craniectomy, or cranioplasty sites. Eligible adults (22–65) who would normally receive a Jackson Pratt or equivalent drain will be treated with MTR therapy for up to seven days. Enrollment is phased to include elective cases, patients with mild-to-moderate TBI (GCS ≥9), and patients with severe TBI (GCS 7–8), with a follow-up visit about one month after treatment. The study will collect safety, feasibility, and fluid-removal outcome data.

Who should consider this trial

Good fit: Adults aged 22–65 undergoing craniotomy, craniectomy, or cranioplasty who require placement of a Jackson Pratt (or equivalent) drain as part of their care are ideal candidates.

Not a fit: Patients outside the age range, those who are pregnant or lactating, those who do not have exposed dura or do not require a JP drain, or those meeting exclusionary acute severe TBI criteria may not receive benefit from this device.

Why it matters

Potential benefit: If successful, MTR could provide a short-term external drainage option to remove post-operative fluid and potentially reduce complications from fluid accumulation.

How similar studies have performed: Although external surgical drains are widely used, the MTR device represents a novel approach and has limited prior clinical experience in this exact setting.

Eligibility criteria

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

Where this trial is running

Buffalo, New York and 2 other locations

• University at Buffalo Neurosurgery — Buffalo, New York, United States (Recruiting)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
• West Virginia University — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Anna M Fryzel, MA

Conditions Clinical Need for Craniotomy or Craniectomy; Clinical Need for Cranioplasty; craniotomy; craniectomy; cranioplasty