Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

Traumatic Intracranial Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728908
• Other study ID #: TICH 01
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 1, 2019

Study information

• Verified date: January 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage, Traumatic
• Intracranial Hemorrhages
• Traumatic Intracranial Hemorrhage

Intervention

Device:
• Medfield Strokefinder MD100
Measurement with Medfield Strokefinder MD100

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital, Department of Surgery, Trauma Unit	Gothenburg	Västra Götaland

Sponsors (3)

Lead Sponsor	Collaborator
Hans Granhed	Chalmers University of Technology, Medfield Diagnostics

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The diagnostic procedure has an estimated duration of 15 minutes
Secondary	The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data		The diagnostic procedure has an estimated duration of 15 minutes
Secondary	The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data		The diagnostic procedure has an estimated duration of 15 minutes
Secondary	Mean time (± standard deviation) needed to complete the measurement procedure		The diagnostic procedure has an estimated duration of 15 minutes
Secondary	Any adverse events occurring within 12 hours from the measurement procedure(s)		The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure