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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgify Safety Burr | Device | Use of Surgify Safety Burr in hard tissue cutting, head and spine area |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate usability of SSB | Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon. | 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 | Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate effectiveness of SSB | Using video material from operations, microphone recording of the surgeon commentary during drilling | Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week. |
| To evaluate beneficiality of SSB |
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Inclusion Criteria:
Exclusion Criteria:
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Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according to other inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Nuutti Vartiainen, MD, PhD | HUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS,Töölö hospital | Helsinki | 00290 | Finland |
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Questionnaires to surgeon |
| Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week |