Detecting Traumatic Intracranial Hemorrhage With Microwave Technology
Primary Purpose
Traumatic Intracranial Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Medfield Strokefinder MD100
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Intracranial Hemorrhage
Eligibility 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.
Sites / Locations
- Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
Outcomes
Primary Outcome Measures
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH
The diagnostic ability of the device is calculated using a leave-one-out/n-fold cross-validation method
Secondary Outcome Measures
The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data
The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data
Mean time (± standard deviation) needed to complete the measurement procedure
Any adverse events occurring within 12 hours from the measurement procedure(s)
Full Information
NCT ID
NCT02728908
First Posted
March 31, 2016
Last Updated
January 29, 2020
Sponsor
Hans Granhed
Collaborators
Medfield Diagnostics, Chalmers University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02728908
Brief Title
Detecting Traumatic Intracranial Hemorrhage With Microwave Technology
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 Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hans Granhed
Collaborators
Medfield Diagnostics, Chalmers University of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Intracranial Hemorrhage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Medfield Strokefinder MD100
Intervention Description
Measurement with Medfield Strokefinder MD100
Primary Outcome Measure Information:
Title
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH
Description
The diagnostic ability of the device is calculated using a leave-one-out/n-fold cross-validation method
Time Frame
The diagnostic procedure has an estimated duration of 15 minutes
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Mean time (± standard deviation) needed to complete the measurement procedure
Time Frame
The diagnostic procedure has an estimated duration of 15 minutes
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Granhed, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Detecting Traumatic Intracranial Hemorrhage With Microwave Technology
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