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

A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04502745

Enrollment

Registered

2020-08-06

Start date

2020-10-01

Completion date

2023-10-23

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subdural Hematoma

Brief summary

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.

Interventions

DEVICEMinimally Invasive Cortical Access System (MICAS)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of all serious adverse events	3 years	Number of adverse events including unanticipated adverse device effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026