Detecting Chronic Subdural Hematoma With Microwave Technology

Sahlgrenska University Hospital

Status

Completed

Conditions

Healthy Volunteers

Chronic Subdural Hematoma

Treatments

Device: Medfield Strokefinder MD100

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02282228

CSH 01

Details and patient eligibility

About

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 for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.

Full 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 volunteers. Patients will be asked to participate in the study, as early as possible after admission. After physical examination, checking the inclusion/exclusion criteria, and after informed consent has been acquired, the microwave-based measurement will be performed. The diagnostic procedure is estimated to take 30 min whereof total subject measurement time will be less than five minutes. Healthy volunteers will be recruited in parallel and the same procedure as for the patients will be followed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the microwave-based investigation is finalized.

To avoid measurement bias all measurements, for both patients and healthy volunteers, will be performed by the same operator.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.