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Detecting Chronic Subdural Hematoma With Microwave Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02282228
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
Medfield Diagnostics
Chalmers University of Technology
Information provided by (Responsible Party):
Dr Thomas Skoglund, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date August 23, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • 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.
  • 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.
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detecting Chronic Subdural Hematoma With Microwave Technology
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Chronic Subdural Hematoma
  • Healthy Volunteers
Intervention  ICMJE Device: Medfield Strokefinder MD100
Measurement with Medfield Strokefinder MD100.
Study Arms  ICMJE Not Provided
Publications * 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 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
40
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282228
Other Study ID Numbers  ICMJE CSH 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Thomas Skoglund, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE
  • Medfield Diagnostics
  • Chalmers University of Technology
Investigators  ICMJE
Principal Investigator: Thomas Skoglund, MD, PhD Sahlgrenska University Hospital, Department of Neurosurgery
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP