A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Ther… (NCT06201429) | Clinical Trial Compass
RecruitingNot Applicable
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.
United States11 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
âś“. 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.
✓. The patient's age is ≥ 22 and ≤ 65 years.
âś“. 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.
âś“. The surgical case is classified as 'clean'.
âś“. All Phase 1 criteria
âś“. Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.
âś“. All Phase 1 criteria
âś“. Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.
Exclusion criteria
âś•. Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
âś•. Patient is pregnant or lactating.
âś•. Patient's BMI \> 45
âś•. Patient is participating in another clinical investigation.
âś•. Patient's anticipated survival is \< 48 hours.