Status:
COMPLETED
Detecting Chronic Subdural Hematoma With Microwave Technology
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Medfield Diagnostics
Chalmers University of Technology
Conditions:
Chronic Subdural Hematoma
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited ...
Detailed Description
This open study will enroll patients admitted for surgery of chronic subdural hematoma at the Department of Neurosurgery at Sahlgrenska University Hospital and compare them to measurements of healthy ...
Eligibility Criteria
Inclusion
- Patient admitted for surgery of chronic subdural hematoma.
- A CT scan of the patient has been performed, within the latest 96 hours.
- The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5.
- Patient/healthy volunteer should be ≥ 18 years of age.
- The patient/healthy volunteer has signed a written informed consent.
Exclusion
- Females who are pregnant or breast feeding women.
- Patient/healthy volunteer has a shunt or other foreign object implanted in the brain.
- Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02282228
Start Date
November 1 2014
End Date
January 1 2016
Last Update
August 23 2018
Active Locations (1)
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1
Sahlgrenska University Hospital, Department of Neurosurgery
Gothenburg, Västra Götaland County, Sweden, 413 45