Back to resultsA Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation
Primary Purpose
Chronic Subdural Hematoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minimally Invasive Cortical Access System (MICAS)
Sponsored by
About this trial
This is an interventional device feasibility trial for Chronic Subdural Hematoma
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance.
Outcomes
Primary Outcome Measures
Incidence of all serious adverse events
Number of adverse events including unanticipated adverse device effects
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04502745
Brief Title
A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation
Official Title
A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance.
Intervention Type
Device
Intervention Name(s)
Minimally Invasive Cortical Access System (MICAS)
Intervention Description
Temporary surgical tool that provides access to the sub-dural space through the cranium.
Primary Outcome Measure Information:
Title
Incidence of all serious adverse events
Description
Number of adverse events including unanticipated adverse device effects
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Van Gompel, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bambi Wessel
Phone
507-293-1963
Email
wessel.bambi@mayo.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Thomas
Phone
507-293-7354
Email
thomas.rebecca2@mayo.edu
First Name & Middle Initial & Last Name & Degree
Jamie J Van Gompel, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation
We'll reach out to this number within 24 hrs