Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

NCT ID: NCT02728908

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-11-01

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.

Conditions

Traumatic Intracranial Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Medfield Strokefinder MD100

Measurement with Medfield Strokefinder MD100

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medfield Diagnostics

INDUSTRY

Sponsor Role: collaborator

Chalmers University of Technology

OTHER

Sponsor Role: collaborator

Hans Granhed

OTHER

Sponsor Role: lead

Responsible Party

Hans Granhed

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hans Granhed, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

Locations

Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

Gothenburg, Västra Götaland County, Sweden

Countries

Sweden

Other Identifiers

TICH 01

Identifier Type: -

Identifier Source: org_study_id