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

Status: Not yet enrolling

Conditions: Clinical Need for Craniotomy or Craniectomy

Treatments: Device: Mechanical Tissue Resuscitation (MTR™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06201429

2023-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Mechanical Tissue Resuscitation (MTR™)

Experimental group

Treatment:

Device: Mechanical Tissue Resuscitation (MTR™)