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Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

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ClinicalTrials.gov Identifier: NCT02728908
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Medfield Diagnostics
Chalmers University of Technology
Information provided by (Responsible Party):
Hans Granhed, Sahlgrenska University Hospital, Sweden

Brief Summary:
An open study evaluating the diagnostic accuracy of a microwave-based device to detect traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with confirmed vs excluded TICH

Condition or disease Intervention/treatment Phase
Traumatic Intracranial Hemorrhage Device: Medfield Strokefinder MD100 Not Applicable

Detailed Description:

This open study will enrol trauma patients admitted to the Trauma Unit, Department of Surgery at Sahlgrenska University Hospital/Sahlgrenska. It will compare patients where TICH has been confirmed by CT (group A) to patients where CT has ruled out TICH (group B). Patients will be asked to participate in the study as early as possible after admission and CT scan. After physical examination, checking inclusion/exclusion criteria, and after informed consent has been acquired, the baseline microwave-based measurement will be performed. The diagnostic procedure is estimated to take 15 min; whereof total subject measurement time will be less than five minutes. Follow-up microwave measurements will be performed in conjunction with any follow-up CTs performed as part of the standard of care, during the hospitalized treatment period. If no follow-up CTs are performed as part of the standard of care, only the baseline microwave measurement will be performed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the last microwave-based investigation is finalized.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detecting Traumatic Intracranial Hemorrhage With Microwave Technology - An Open Study Evaluating the Diagnostic Accuracy of a Microwave-based Device to Detect Traumatic Intracranial Hemorrhage (TICH), by Comparing Measurements on Trauma Patients With Confirmed vs Excluded TICH
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Device: Medfield Strokefinder MD100
    Measurement with Medfield Strokefinder MD100


Primary Outcome Measures :
  1. The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes ]
    The diagnostic ability of the device is calculated using a leave-one-out/n-fold cross-validation method


Secondary Outcome Measures :
  1. The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes ]
  2. The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes ]
  3. Mean time (± standard deviation) needed to complete the measurement procedure [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes ]
  4. Any adverse events occurring within 12 hours from the measurement procedure(s) [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient admitted to Sahlgrenska University Hospital for trauma care.
  • Patient deemed clinically stable.
  • Patient should have a Glasgow Coma Scale rating of > 14
  • TICH confirmed (group A) or ruled out (group B) by CT, performed within the latest 12 hours.
  • Patient ≥ 18 years of age.
  • Patient has signed the Informed Consent Form.

Exclusion Criteria:

  • Patient has confirmed or suspected skull fracture.
  • Patient has confirmed or suspected cervical spine fracture.
  • The diagnostic procedure is deemed to interfere with the standard of care.
  • Patient has a shunt or other foreign object implanted intracranially.
  • Patient has agraffes/other metal parts, thick (> 1 cm) bandage, or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
  • Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgment.
  • Females who are pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728908


Contacts
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Contact: Hans Granhed, MD, PhD +4670-926 21 48 hans.granhed@vgregion.se
Contact: Mikael Elam, MD, PhD +4670-940 10 42 mikael.elam@neuro.gu.se

Locations
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Sweden
Sahlgrenska University Hospital, Department of Surgery, Trauma Unit Recruiting
Gothenburg, Västra Götaland, Sweden, 413 45
Contact: Hans Granhed, MD, PhD    +4670-926 21 48    hans.granhed@vgregion.se   
Contact: Mikael Elam, MD, PhD    +4670-940 10 42    mikael.elam@neuro.gu.se   
Principal Investigator: Hans Granhed, MD, PhD         
Sub-Investigator: Eva-Corina Caragounis, MD         
Sub-Investigator: Karin Sillén, MD         
Sub-Investigator: Per Örtenwall, MD, PhD         
Sponsors and Collaborators
Hans Granhed
Medfield Diagnostics
Chalmers University of Technology
Investigators
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Principal Investigator: Hans Granhed, MD, PhD Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

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Responsible Party: Hans Granhed, Sponsor-Investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02728908     History of Changes
Other Study ID Numbers: TICH 01
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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