Early Feasibility Study of the Mechanical Tissue Resuscitation4 Therapy System to Drain Excess Fluid After Skull Surgery in Adults Aged 22 to 65

What this Trial Is About

This research aims to evaluate the Mechanical Tissue Resuscitation MTR therapy system for removing excess fluid in patients who have undergone surgery removing a portion of the skull, exposing the dura or brain, and requiring fluid drainage. The study includes patients aged 22 to 65 who need craniotomy, craniectomy, or cranioplasty and require placement of a Jackson Pratt drain or equivalent. The trial is a multi-center, early feasibility study conducted in phases based on patient condition severity. Participants will receive the MTR device therapy for up to 7 days to externally drain fluid from the surgical site. The study has three phases Phase 1 includes patients undergoing elective procedures Phase 2 involves patients with mild-to-moderate traumatic brain injury TBI with a Glasgow Coma Scale GCS of 9 or above and two reactive pupils Phase 3 includes patients with severe TBI defined by a GCS of 7 or 8 and two reactive pupils. Treatment is followed by an evaluation about one month after therapy. During the study, patients will be monitored for safety and effectiveness of the MTR therapy over 30 days. Researchers will assess the ability to remove fluid during the 7-day treatment, record any adverse events, and gather feedback on ease of device use from operators and healthcare professionals on the day of surgery. Data integrity will also be monitored. The total participation includes treatment and follow-up assessments to evaluate outcomes and safety.

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.