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Clinical Trials in the USA / NCT06201429
Recruiting Not applicable

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.

NCT06201429 · tracked via the Priya Life Science USA tracker
Sponsor
Renovo Concepts, Inc.
Phase
Not applicable
Started
2024-11-01
Last updated
2026-05-04

Condition(s) studied

Clinical Need for Craniotomy or CraniectomyClinical Need for Cranioplasty

Investigational drug(s) / intervention(s)

Mechanical Tissue Resuscitation™ (MTR®)

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

Sex
ALL
Min age
22 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
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
Official registry record

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