Clinical Need for Cranioplasty, Clinical Need for Craniotomy or Craniectomy
Conditions
Keywords
craniotomy, craniectomy, cranioplasty
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), 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
DEVICEMechanical 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).
Sponsors
Renovo Concepts, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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/cranioplasty.
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Phase 1: 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. 2. The patient's age is ≥ 22 and ≤ 65 years. 3. 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. 4. The surgical case is classified as 'clean'. Phase 2: 1. All Phase 1 criteria 2. Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils. Phase 3: 1. All Phase 1 criteria 2. Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.
Exclusion criteria
Phase 1: 1. Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13. 2. Patient is pregnant or lactating. 3. Patient's BMI \> 45 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 a known active opioid abuser at the time of surgery. 11. Patient is a known active alcohol abuser at the time of surgery. 12. Active bleeding at the site of surgery prior to placement of the device. Phases 2 and 3: 1\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and effectiveness of MTR® | 30 days | The primary endpoint is to evaluate that MTR® is safe for the removal of fluids in those patients who have undergone a craniotomy/craniectomy/cranioplasty. This endpoint will be assessed by the frequency of device and procedure related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MTR® Success | 30 days | MTR® Success will be defined as: 1. Placement: ability to establish and maintain pressure with adequate manifold sizing. 2. Maintenance: lack of air leaks and evidence of fluid removal. 3. Removal: ability to remove without tissue damage or excessive bleeding. |
| AEs/SAEs Frequency | 30 days | Frequency of all adverse events experienced from the time of enrollment through study exit. Events will be categorized as adverse events (AEs) or serious adverse events (SAEs) and measured by site data entry review. |
| Ability to remove fluid | 7 days | Ability to remove fluid, measured volume of fluid and rate of removal. |
| Operator ease survey | 1 day (during day of surgery) | Operator survey measured by completion of the following 3 questions on the case report form for: 1. ease of manifold placement, 2. ease of exit tubing placement, 3. ease of establishment of a vacuum seal. Answered with a five category Likert scale ranging from Extremely Easy to Extremely Difficult. |
| Health care professional (HCP) ease survey | 1 day (during day of surgery) | HCP survey regarding ease of system use/maintenance during treatment period. Answered with a four category Likert scale ranging from Poor to Excellent for each specific category below: 1. MTR Manifold (silicone foam) Sheet Placement 2. Dome and Tubing Assembly Placement 3. Use of Sub-Atmospheric Pressure Pump (SaPP®) 4. Vacuum - Site closure 5. Fluid Removal |
| Data Integrity | 30 days | Data integrity measured by the frequency of each type of missing data query seen during the course of the subject's treatment, and frequency of any other protocol deviation recorded during the study. |
Countries
United States
Contacts
CONTACTAnna M Fryzel, MA
Outcome results
None listed