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.
Renovo Concepts, Inc.
11 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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.
Exclusion Criteria14
- 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:
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Mechanical Tissue Resuscitation™ (MTR®) to drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06201429