Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
Renovo Concepts, Inc.
Conditions:
Clinical Need for Craniotomy or Craniectomy
Eligibility:
All Genders
22-65 years
Phase:
NA
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 exp...
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 procedur...
Eligibility Criteria
Inclusion
- Patient is willing and able to provide written informed consent.
- The patient's age is ≥ 22 and ≤ 65 years.
- 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.
- The surgical case is classified as 'clean'.
Exclusion
- Patient has suffered a traumatic brain injury.
- Patient is pregnant or lactating.
- 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
- Patient is participating in another clinical investigation .
- Patient's anticipated survival is \< 48 hours.
- Patient is incarcerated at time of hospital admission.
- Patient has a coincidental infection.
- Patient has thrombocytopenia (platelet count \< 150,000/µL).
- Patient has an International Normalized Ratio (INR) \> 1.5.
- Patient is an active opioid abuser.
- Patient is an active alcohol abuser.
- There is active bleeding at the site of surgery.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06201429
Start Date
January 15 2024
End Date
June 15 2024
Last Update
January 24 2024
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