Detecting Chronic Subdural Hematoma With Microwave Technology

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Chronic Subdural Hematoma
• Intervention / Treatment: Device: Medfield Strokefinder MD100

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 413 45
      • Sahlgrenska University Hospital, Department of neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Chalmers University of Technology; Medfield Diagnostics
• Investigators: Principal Investigator: Thomas Skoglund, MD, PhD, Sahlgrenska University Hospital, Department of neurosurgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: CSH 01