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

Not Applicable

Terminated

• Conditions: Chronic Subdural Hematoma
• Interventions: Device: Minimally Invasive Cortical Access System (MICAS)

• Registration Number: NCT04502745
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Study Start: 2020-10-01
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Minimally Invasive Cortical Access System (MICAS)	During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance.

Primary Outcome Measures

Name	Time	Method
Incidence of all serious adverse events	3 years	Number of adverse events including unanticipated adverse device effects

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States