Clinical Trial: Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Detecting Traumatic Intracranial Hemorrhage With Microwave Technology - An Open Study Evaluating the Diagnostic Accuracy of a Microwave-based Device to Detect

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 Summary:

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.


Sponsor: Hans Granhed

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: March 31, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: January 19, 2017
Last Verified: January 2017