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Cortical Access System

MICAS for Chronic Subdural Hematoma

N/A

Recruiting

Led By Jamie Van Gompel, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new, less-invasive way to remove old blood from the space between the brain and its membrane.

Who is the study for?

This trial is for individuals aged 55 or older who have a chronic subdural hematoma (a type of brain bleed) that's more than 1 cm thick and needs draining. Participants must be able to give consent, not belong to a vulnerable group, not require ongoing blood thinners, and cannot be pregnant or have had prior surgery for this condition.Check my eligibility

What is being tested?

The study is testing the Minimally Invasive Cortical Access System (MICAS), which aims to offer a less invasive way to remove old blood from beneath the skull's inner layer compared to current methods.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with minimally invasive brain procedures such as infection, bleeding, neurological deficits, and reactions specific to the MICAS device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 55 years old or older.

Select...

I have a significant brain bleed needing surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of all serious adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,028 Total Patients Enrolled

Jamie Van Gompel, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for willing participants in this experiment?

"This study, which was first posted on October 1, 2020, is currently recruiting participants, as reported on clinicaltrials.gov."

Answered by AI

How many people are signed up to help test this new medication?

"That is correct, the information available on clinicaltrials.gov shows that this trial is still looking for patients. The trial was originally posted on October 1st 2020 and was updated on November 6th 2021. They are looking for a total of 10 patients between 1 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jamie J. Van Gompel 2020. "A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502745.