Clinical trial NCT02282228: Detecting Chronic Subdural Hematoma With Microwave Technology
Official title: Detecting Chronic Subdural Hematoma With Microwave Technology - An Open Study Evaluating the Sensitivity and Specificity of a Microwave-based Device, Medfield Strokefinder MD100, to Detect Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Subdural Hematoma
Healthy Volunteers
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Medfield Diagnostics
name: Chalmers University of Technology
First posted: 2014-11-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm.
timeFrame: The diagnostic procedure has an estimated duration of 30 minutes.
Secondary outcomes:
measure: Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of microwave data.
timeFrame: The diagnostic procedure has an estimated duration of 30 minutes.
measure: Classification accuracy for estimating the position of the subdural hematoma through a mathematical analysis of the microwave data.
timeFrame: The diagnostic procedure has an estimated duration of 30 minutes.
measure: Mean (± standard deviation) signal amplitude and phase shift caused by presence of chronic subdural hematoma.
timeFrame: The diagnostic procedure has an estimated duration of 30 minutes.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Department of Neurosurgery
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Neurosurgery
name: Thomas Skoglund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ljungqvist J, Candefjord S, Persson M, Jonsson L, Skoglund T, Elam M. Clinical Evaluation of a Microwave-Based Device for Detection of Traumatic Intracranial Hemorrhage. J Neurotrauma. 2017 Jul 1;34(13):2176-2182. doi: 10.1089/neu.2016.4869. Epub 2017 Mar 13.