Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detecting Traumatic Intracranial Hemorrhage 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: NCT02728908
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : January 31, 2020
Sponsor:
Collaborators:
Medfield Diagnostics
Chalmers University of Technology
Information provided by (Responsible Party):
Hans Granhed, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date January 31, 2020
Study Start Date  ICMJE April 2016
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2016)
  • 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 ]
  • 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 ]
  • Mean time (± standard deviation) needed to complete the measurement procedure [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • The accuracy for estimating the position and 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 ]
  • Mean time (± standard deviation) needed to complete the measurement procedure [ Time Frame: The diagnostic procedure has an estimated duration of 15 minutes ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detecting Traumatic Intracranial Hemorrhage With Microwave Technology
Official Title  ICMJE 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
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.

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 Traumatic Intracranial Hemorrhage
Intervention  ICMJE Device: Medfield Strokefinder MD100
Measurement with Medfield Strokefinder MD100
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: March 31, 2016)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02728908
Other Study ID Numbers  ICMJE TICH 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hans Granhed, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Hans Granhed
Collaborators  ICMJE
  • Medfield Diagnostics
  • Chalmers University of Technology
Investigators  ICMJE
Principal Investigator: Hans Granhed, MD, PhD Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date January 2020

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