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Detecting Chronic Subdural Hematoma With Microwave Technology

This study has been completed.
Sponsor:
Collaborators:
Medfield Diagnostics
Chalmers University of Technology
Information provided by (Responsible Party):
Dr Thomas Skoglund, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT02282228
First received: October 22, 2014
Last updated: February 3, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Chronic Subdural Hematoma
Healthy Volunteers
Device: Medfield Strokefinder MD100

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]

Enrollment: 41
Study Start Date: November 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Medfield Strokefinder MD100
    Measurement with 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02282228

Locations
Sweden
Sahlgrenska University Hospital, Department of Neurosurgery
Gothenburg, Västra Götaland, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Medfield Diagnostics
Chalmers University of Technology
Investigators
Principal Investigator: Thomas Skoglund, MD, PhD Sahlgrenska University Hospital, Department of Neurosurgery
  More Information

Responsible Party: Dr Thomas Skoglund, Principal Investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02282228     History of Changes
Other Study ID Numbers: CSH 01
Study First Received: October 22, 2014
Last Updated: February 3, 2016

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural, Chronic
Hematoma, Subdural
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 24, 2017