RecruitingNot ApplicableNCT06201429

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.


Sponsor

Renovo Concepts, Inc.

Enrollment

11 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Mechanical Tissue Resuscitation™ (MTR®) for people with clinical need for cranioplasty and clinical need for craniotomy or craniectomy. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 22 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMechanical Tissue Resuscitation™ (MTR®)

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).


Locations(3)

University at Buffalo Neurosurgery

Buffalo, New York, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

West Virginia University

Morgantown, West Virginia, United States

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NCT06201429