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.

Recruiting N/A Interventional Study
Clinical Need for Craniotomy or Craniectomy Clinical Need for Cranioplasty
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 – 65
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
11 (estimated)
Sponsor
Renovo Concepts, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Phase 1: 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. 2. The patient's age is ≥ 22 and ≤ 65 years. 3. The patient has a clinical need for a craniot…
Contacts

Anna M Fryzel, MA

1 978-760-6582

anna.fryzel@avaniaclinical.com

CONTACT