Clinical Need for Craniotomy or Craniectomy Clinical Trial
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.
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.
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) in which the dura is intact or has been closed (repaired), and who, as an integral part of their care would require placement of a Jackson Pratt drain. Patients will be treated with MTR™ for up to seven (7) days, with a follow up evaluation approximately one month post treatment. Patients who have suffered a traumatic brain injury (TBI) and require such a surgical procedure are not to be included in the patient population for this early feasibility study. ;