Clinical trial NCT06201429: 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.
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical Need for Craniotomy or Craniectomy
Keywords: craniotomy
craniectomy
Lead sponsor: Renovo Concepts, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 9
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and effectiveness of MTR™
timeFrame: 30 days
Secondary outcomes:
measure: MTR™ Success
timeFrame: 30 days
measure: AEs/SAEs Frequency
timeFrame: 30 days
measure: Ability to remove fluid
timeFrame: 7 days
measure: Operator ease survey
timeFrame: 1 day (during day of surgery)
measure: Health care professional (HCP) ease survey
timeFrame: 1 day (during day of surgery)
measure: Data Integrity
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: