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.

Conditions

• Clinical Need for Cranioplasty
• Clinical Need for Craniotomy or Craniectomy

Eligibility Criteria

Sex

ALL

Age

22 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Mechanical Tissue Resuscitation™ (MTR®) — DEVICE
  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).

Study Details

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.

Key Dates

Start date

Nov 1, 2024

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

11 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Mechanical Tissue Resuscitation™ (MTR®)

Primary Outcome Measure

Safety and effectiveness of MTR® [ Time Frame: 30 days ]

Central Contacts

• Anna M Fryzel, MA
  1 978-760-6582
  [email protected]

Locations (3)

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