NCT02282228

Detecting Chronic Subdural Hematoma With Microwave Technology

Detecting Chronic Subdural Hematoma With Microwave Technology - An Open Study Evaluating the Sensitivity and Specificity of a Microwave-based Device, Medfield Strokefinder MD100, to Detect Chronic Subdural Hematoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-11-04
• Last updated: 2018-08-23

Locations

1 site across 1 country: Sweden