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NCT04502745 Clinical Trial

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

Chronic Subdural Hematoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04502745
Other study ID # 20-005086
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date October 23, 2023

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date October 23, 2023
Est. primary completion date October 23, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Minimally Invasive Cortical Access System (MICAS)
Temporary surgical tool that provides access to the sub-dural space through the cranium.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of all serious adverse events Number of adverse events including unanticipated adverse device effects 3 years
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