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.

Recruiting now · Not applicable

Conditions studied: Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty

In brief

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.

Key facts

Study ID

NCT06201429

Run by

Renovo Concepts, Inc.

People needed

11

Starts

2024-11-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-04

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase 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.
• The patient's age is ≥ 22 and ≤ 65 years.
• 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.
• The surgical case is classified as 'clean'.
• Phase 2:
• All Phase 1 criteria
• Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.
• Phase 3:
• All Phase 1 criteria
• Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.

You may not qualify if…

• Phase 1:
• Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
• Patient is pregnant or lactating.
• Patient's BMI > 45
• Patient is participating in another clinical investigation.
• Patient's anticipated survival is < 48 hours.
• Patient is incarcerated at time of hospital admission.
• Patient has a coincidental infection.
• Patient has thrombocytopenia (platelet count < 150,000/µL).
• Patient has an International Normalized Ratio (INR) > 1.5.
• Patient is a known active opioid abuser at the time of surgery.
• Patient is a known active alcohol abuser at the time of surgery.
• Active bleeding at the site of surgery prior to placement of the device.
• Phases 2 and 3:
• Exclusion criteria 2-12 from Phase 1

Where it is running

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

Full record on ClinicalTrials.gov

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