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.
Condition(s) studied
Investigational drug(s) / intervention(s)
Mechanical Tissue Resuscitation™ (MTR®): 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).
Study 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
Primary outcome measure(s)
- Safety and effectiveness of MTR® — 30 days
The primary endpoint is to evaluate that MTR® is safe for the removal of fluids in those patients who have undergone a craniotomy/craniectomy/cranioplasty. This endpoint will be assessed by the frequency of device and procedure related adverse events.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| University at Buffalo Neurosurgery | Buffalo | New York | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06201429 on ClinicalTrials.gov ↗ ← All trials in the USA