Detecting Chronic Subdural Hematoma With Microwave Technology

NCT ID: NCT02282228

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-01-31

Brief Summary

An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.

Detailed Description

This open study will enroll patients admitted for surgery of chronic subdural hematoma at the Department of Neurosurgery at Sahlgrenska University Hospital and compare them to measurements of healthy volunteers. Patients will be asked to participate in the study, as early as possible after admission. After physical examination, checking the inclusion/exclusion criteria, and after informed consent has been acquired, the microwave-based measurement will be performed. The diagnostic procedure is estimated to take 30 min whereof total subject measurement time will be less than five minutes. Healthy volunteers will be recruited in parallel and the same procedure as for the patients will be followed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the microwave-based investigation is finalized.

To avoid measurement bias all measurements, for both patients and healthy volunteers, will be performed by the same operator.

Conditions

Chronic Subdural Hematoma; Healthy Volunteers

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 for surgery of chronic subdural hematoma.
• A CT scan of the patient has been performed, within the latest 96 hours.
• The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5.
• Patient/healthy volunteer should be ≥ 18 years of age.
• The patient/healthy volunteer has signed a written informed consent.

Exclusion Criteria

• Females who are pregnant or breast feeding women.
• Patient/healthy volunteer has a shunt or other foreign object implanted in the brain.
• Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medfield Diagnostics

INDUSTRY

Sponsor Role: collaborator

Chalmers University of Technology

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Thomas Skoglund

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Skoglund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital, Department of Neurosurgery

Locations

Sahlgrenska University Hospital, Department of Neurosurgery

Gothenburg, Västra Götaland County, Sweden

Countries

Sweden

References

Ljungqvist J, Candefjord S, Persson M, Jonsson L, Skoglund T, Elam M. Clinical Evaluation of a Microwave-Based Device for Detection of Traumatic Intracranial Hemorrhage. J Neurotrauma. 2017 Jul 1;34(13):2176-2182. doi: 10.1089/neu.2016.4869. Epub 2017 Mar 13.

Reference Type: RESULT

PMID: 28287909 (View on PubMed)

Other Identifiers

CSH 01

Identifier Type: -

Identifier Source: org_study_id