NCT02728908

Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Hans Granhed · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Intracranial Hemorrhage

Interventions

Type	Name	Description
DEVICE	Medfield Strokefinder MD100	Measurement with Medfield Strokefinder MD100

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-04-05
• Last updated: 2020-01-31

Locations

1 site across 1 country: Sweden