Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.
Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.
Study Type
OBSERVATIONAL
Enrollment
22
Use of Surgify Safety Burr in hard tissue cutting, head and spine area
HUS,Töölö hospital
Helsinki, Finland
To evaluate usability of SSB
Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon.
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
To evaluate safety of SSB
AE reporting
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
To evaluate effectiveness of SSB
Using video material from operations, microphone recording of the surgeon commentary during drilling
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
To evaluate beneficiality of SSB
Questionnaires to surgeon
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week
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