Early Study of MTR® System for Fluid Removal After Skull Surgery
This study is testing a device called the Mechanical Tissue Resuscitation™ (MTR®) Therapy System. It's designed to remove extra fluid from the surgical site after you've had a part of your skull removed (craniotomy or craniectomy) or repaired (cranioplasty). The study aims to see if the MTR® system is safe and works well for this purpose. You might be able to join if you are between 22 and 65 years old and need this type of surgery and fluid drainage. The study plans to enroll 11 participants, but its current status is unclear.
- Study design
- This is an early feasibility study, meaning it's one of the first times this device is being tested in people. It's a single-arm study, so all 11 participants will receive the MTR® therapy.
- What's involved
- The MTR® system is intended for short-term use, up to 7 days, to drain fluid from your surgical site.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and how well the MTR® system works will be checked for 30 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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.
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- 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.