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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mechanical Tissue Resuscitation™ (MTR®).
- Who it may be relevant to
- Registry conditions: Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty. Basic parameters: 22 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).
The study will be conducted in subsequent phases, to enroll patients in the following populations:
* Phase 1: patients undergoing elective procedures; * Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and * Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils.
Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.
Interventions
- Device Mechanical Tissue Resuscitation™ (MTR®)
Mechanical Tissue Resuscitation™ (MTR®) to drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).
Primary outcome measures
- Safety and effectiveness of MTR® [Time frame: 30 days]
Secondary outcome measures (6)
- MTR® Success [Time frame: 30 days]
- AEs/SAEs Frequency [Time frame: 30 days]
- Ability to remove fluid [Time frame: 7 days]
- Operator ease survey [Time frame: 1 day (during day of surgery)]
- Health care professional (HCP) ease survey [Time frame: 1 day (during day of surgery)]
- Data Integrity [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
Phase 1:
- 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.
- 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.
- The surgical case is classified as 'clean'.
Phase 2:
- All Phase 1 criteria
- Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.
Phase 3:
- All Phase 1 criteria
- Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.
Exclusion criteria
Phase 1:
- Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
- Patient is pregnant or lactating.
- Patient's BMI > 45
- 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 a known active opioid abuser at the time of surgery.
- Patient is a known active alcohol abuser at the time of surgery.
- Active bleeding at the site of surgery prior to placement of the device.
Phases 2 and 3:
1\. Exclusion criteria 2-12 from Phase 1
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 3 centers
- University at Buffalo Neurosurgery — Buffalo
- Atrium Health Wake Forest Baptist — Winston-Salem
- West Virginia University — Morgantown
Identifiers
NCT: NCT06201429 · 2023-01