Status:
TERMINATED
A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation
Lead Sponsor:
Mayo Clinic
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
55+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04502745
Start Date
October 1 2020
End Date
October 23 2023
Last Update
May 10 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905