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

Mayo Clinic

Status: Terminated

Conditions: Chronic Subdural Hematoma

Treatments: Device: Minimally Invasive Cortical Access System (MICAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04502745

20-005086

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Treatment Group

Experimental group

Description:

During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance.

Treatment:

Device: Minimally Invasive Cortical Access System (MICAS)