NCT06201429NARecruiting

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.

Start Date

11/1/2024

Completion Date

12/31/2026

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.

Detailed Description

Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid. This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy. The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or 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). The study will be conducted in subsequent phases, to enroll patients in the following populations: * Phase 1: patients undergoing elective procedures; * Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and * Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils. Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

Eligibility Criteria

Age Range: 22 years to 65 years

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

Interventions

DEVICE

Mechanical Tissue Resuscitation™ (MTR®)

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Conditions

Clinical Need for Craniotomy or CraniectomyClinical Need for Cranioplasty

Locations

University at Buffalo Neurosurgery

Buffalo, New York 14203

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

West Virginia University

Morgantown, West Virginia 26506

United States