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.

Not Applicable

Not yet recruiting

• Conditions: Clinical Need for Craniotomy or Craniectomy

• Registration Number: NCT06201429
• Lead Sponsor: Renovo Concepts, Inc.

Brief 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) in which the dura is intact or has been closed (repaired), and who, as an integral part of their care would require placement of a Jackson Pratt drain.

Patients will be treated with MTR™ for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

Patients who have suffered a traumatic brain injury (TBI) and require such a surgical procedure are not to be included in the patient population for this early feasibility study.

Study Timeline

• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2023-12-30
• Status Verified: 2024-01
• Study First Posted: 2024-01-11
• Study Start: 2024-01-15
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-04-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Patient is willing and able to provide written informed consent.
2. The patient's age is ≥ 22 and ≤ 65 years.
3. The patient has a clinical need for a craniotomy/craniectomy and for which, as an integral part of their care, a Jackson Pratt (JP) drain would be placed at the surgical site.
4. The surgical case is classified as 'clean'.

Exclusion Criteria

1. Patient has suffered a traumatic brain injury.
2. Patient is pregnant or lactating.
3. Patient's BMI = (Weight (lb) x 703)/(〖Height〗^2 (inches)) > 45; BMI may also be calculated at http://nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm
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 an active opioid abuser.
11. Patient is an active alcohol abuser.
12. There is active bleeding at the site of surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and effectiveness of MTR™	30 days	The primary endpoint is to evaluate MTR™ as safe and effective for the removal of fluids in those patients who have undergone a craniotomy/craniectomy, and to assess the frequency of device and procedure related adverse events.

Secondary Outcome Measures

Name	Time	Method
Ability to remove fluid	7 days	Ability to remove fluid, measured volume of fluid and rate of removal.
MTR™ Success	30 days	MTR™ Success will be defined as: 1. Placement: ability to establish and maintain pressure with adequate manifold sizing.; 2. Maintenance: lack of air leaks and evidence of fluid removal.; 3. Removal: ability to remove without tissue damage or excessive bleeding.
Data Integrity	30 days	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.
Operator ease survey	1 day (during day of surgery)	Operator survey measured by completion of the following 3 questions on the case report form for: 1. ease of manifold placement,; 2. ease of exit tubing placement,; 3. ease of establishment of a vacuum seal.; Answered with a five category Likert scale ranging from Extremely Easy to Extremely Difficult.
AEs/SAEs Frequency	30 days	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.
Health care professional (HCP) ease survey	1 day (during day of surgery)	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: 1. MTR Manifold (silicone foam) Sheet Placement; 2. Dome and Tubing Assembly Placement; 3. Use of Sub-Atmospheric Pressure Pump (SaPP™); 4. Vacuum - Site closure; 5. Fluid Removal