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New treatment option for Clinical Need for Craniotomy or Craniectomy
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.
ClinicalTrials.gov ID: NCT06201429
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Phase 1:
- Patient is willing and able to provide written informed consent or has an appointed legally authorized representative (LAR) who can provide consent...
- 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)...
- The surgical case is classified as 'clean'. Phase 2:
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
- Winston-Salem, North Carolina, United States
- Morgantown, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States; Winston-Salem, North Carolina, United States; Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.