Detecting Chronic Subdural Hematoma With Microwave Technology

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282228
• Other study ID #: CSH 01
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2018
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Healthy Volunteers
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Device:
• Medfield Strokefinder MD100
Measurement with Medfield Strokefinder MD100.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital, Department of Neurosurgery	Gothenburg	Västra Götaland

Sponsors (3)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Chalmers University of Technology, Medfield Diagnostics

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Ljungqvist J, Candefjord S, Persson M, Jönsson 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm.	The diagnostic ability of the device is calculated using a leave-one-out cross-validation method.	The diagnostic procedure has an estimated duration of 30 minutes.
Secondary	Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of microwave data.	Pearson's linear correlation coefficient is calculated by comparing subdural hematoma volumes estimated by analysis of CT image and by a mathematical analysis of the microwave data.	The diagnostic procedure has an estimated duration of 30 minutes.
Secondary	Classification accuracy for estimating the position of the subdural hematoma through a mathematical analysis of the microwave data.	The ability of the device to estimate location of subdural hematoma is evaluated using a classification algorithm and leave-one-out cross validation.	The diagnostic procedure has an estimated duration of 30 minutes.
Secondary	Mean (± standard deviation) signal amplitude and phase shift caused by presence of chronic subdural hematoma.		The diagnostic procedure has an estimated duration of 30 minutes.