Status:
COMPLETED
Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke
Lead Sponsor:
Medfield Diagnostics
Conditions:
Stroke
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers. The main purpose of the study ...
Detailed Description
After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After subject enrollment the microwave measureme...
Eligibility Criteria
Inclusion
- (Group A)
- Signed Informed Consent Form
- Patient diagnosed (by CT) with ischemic stroke, within 24 hours of stroke onset
- Patient should be ≥ 18 years of age
- (Group B)
- Signed Informed Consent Form
- Patient diagnosed (by CT) with hemorrhagic stroke, within 48 hours of stroke onset
- Patient should be ≥ 18 years of age
- (Group C)
- Signed Informed Consent Form
- Subject should be ≥ 18 years of age
Exclusion
- (Group A+B)
- Pregnant or nursing woman
- Woman of child bearing potential and not taking adequate contraceptive precautions
- Patient that has already received thrombolytic treatment
- Patient participating in any other clinical study that could interfere with the result in the present study
- Patient diagnosed with a condition associated with risk of poor protocol compliance
- Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
- Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrollment
- (Group C)
- Pregnant or nursing woman
- Woman of child bearing potential and not taking adequate contraceptive precautions
- Subject participating in any other clinical study that could interfere with the result in the present study
- Any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment
- Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT02266459
Start Date
October 1 2014
End Date
July 1 2015
Last Update
August 11 2015
Active Locations (3)
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1
Strokeenheten, Södra Älvsborgs Sjukhus
Borås, Borås, Sweden, 501 82
2
Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology
Gothenburg, Göteborg, Sweden, 41345
3
Strokeenheten, Skaraborgs Sjukhus
Skövde, Sweden, 541 42