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

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 Overview

• Status: Terminated
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Device: Minimally Invasive Cortical Access System (MICAS)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance.	Device: Minimally Invasive Cortical Access System (MICAS); Temporary surgical tool that provides access to the sub-dural space through the cranium.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jamie Van Gompel, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 20-005086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes