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OpenTrials
Completed

NCT Number: NCT02282228

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, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medfield Strokefinder MD100

Device

Measurement with Medfield Strokefinder MD100.

Primary outcomes

  1. Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm.

    Time frame: The diagnostic procedure has an estimated duration of 30 minutes.

    The diagnostic ability of the device is calculated using a leave-one-out cross-validation method.

Secondary outcomes

  1. Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of microwave data.

    Time frame: The diagnostic procedure has an estimated duration of 30 minutes.

    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.

  2. Classification accuracy for estimating the position of the subdural hematoma through a mathematical analysis of the microwave data.

    Time frame: The diagnostic procedure has an estimated duration of 30 minutes.

    The ability of the device to estimate location of subdural hematoma is evaluated using a classification algorithm and leave-one-out cross validation.

  3. Mean (± standard deviation) signal amplitude and phase shift caused by presence of chronic subdural hematoma.

    Time frame: The diagnostic procedure has an estimated duration of 30 minutes.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Chalmers University of Technology
  • Medfield Diagnostics

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2014
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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