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.

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.

Study Overview

• Status: Recruiting
• Conditions: Clinical Need for Craniotomy or Craniectomy; Clinical Need for Cranioplasty
• Intervention / Treatment: Device: Mechanical Tissue Resuscitation™ (MTR®)

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.

• Study Type: Interventional
• Enrollment (Estimated): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna M Fryzel, MA; Phone Number: 1 978-760-6582; Email: anna.fryzel@avaniaclinical.com

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo Neurosurgery
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mechanical Tissue Resuscitation™ (MTR®)

Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and effectiveness of MTR®	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs/SAEs Frequency	Frequency of all adverse events experienced from the time of enrollment through study exit. Events will be categorized as adverse events (AEs) or serious adverse events (SAEs) and measured by site data entry review.	30 days
Ability to remove fluid	Ability to remove fluid, measured volume of fluid and rate of removal.	7 days
Operator ease survey	Operator survey measured by completion of the following 3 questions on the case report form for: ease of manifold placement,; ease of exit tubing placement,; ease of establishment of a vacuum seal. Answered with a five category Likert scale ranging from Extremely Easy to Extremely Difficult.	1 day (during day of surgery)
Data Integrity	Data integrity measured by the frequency of each type of missing data query seen during the course of the subject's treatment, and frequency of any other protocol deviation recorded during the study.	30 days
MTR® Success	MTR® Success will be defined as: Placement: ability to establish and maintain pressure with adequate manifold sizing.; Maintenance: lack of air leaks and evidence of fluid removal.; Removal: ability to remove without tissue damage or excessive bleeding.	30 days
Health care professional (HCP) ease survey	HCP survey regarding ease of system use/maintenance during treatment period. Answered with a four category Likert scale ranging from Poor to Excellent for each specific category below: MTR Manifold (silicone foam) Sheet Placement; Dome and Tubing Assembly Placement; Use of Sub-Atmospheric Pressure Pump (SaPP®); Vacuum - Site closure; Fluid Removal	1 day (during day of surgery)

Collaborators and Investigators

• Sponsor: Renovo Concepts, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: craniotomy; craniectomy; cranioplasty
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes