A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation

Mayo Clinic6 enrolled

Overview

The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Chronic Subdural Hematoma

Interventions

Minimally Invasive Cortical Access System (MICAS)DEVICE

Temporary surgical tool that provides access to the sub-dural space through the cranium.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be 55 years of age or greater. * Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation. Exclusion Criteria: * Failure to obtain consent. * Vulnerable study population. * Any need for chronic anticoagulation. * Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma. * Glasgow Coma Scale (GCS) less than 8.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Incidence of all serious adverse events

Number of adverse events including unanticipated adverse device effects

Time frame: 3 years

Data from ClinicalTrials.gov

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