Actively Recruiting
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.
Led by Renovo Concepts, Inc. · Updated on 2026-05-04
11
Participants Needed
3
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is willing and able to provide written informed consent or has a legally authorized representative who can consent on their behalf.
- Age is between 22 and 65 years.
- Clinical need for craniotomy, craniectomy, or cranioplasty with placement of a Jackson Pratt drain or equivalent at the surgical site.
- Surgical case is classified as clean.
- For phase 2, patient has mild-to-moderate traumatic brain injury with Glasgow Coma Scale (GCS) score of 9 or above and two reactive pupils.
- For phase 3, patient has acute severe traumatic brain injury with GCS of 7-8 and two reactive pupils.
You will not qualify if you...
- Acute severe traumatic brain injury less than 7 days since injury with GCS less than 13 (phase 1).
- Patient is pregnant or lactating.
- Body mass index (BMI) greater than 45.
- Participation in another clinical investigation.
- Anticipated survival less than 48 hours.
- Patient is incarcerated at hospital admission.
- Presence of coincidental infection.
- Thrombocytopenia (platelet count less than 150,000/b5L).
- International Normalized Ratio (INR) greater than 1.5.
- Known active opioid abuse at time of surgery.
- Known active alcohol abuse at time of surgery.
- Active bleeding at surgical site before device placement.
- For phases 2 and 3, exclusion criteria 2-12 from phase 1 also apply.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14203
Actively Recruiting
2
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
A
Anna M Fryzel, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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