Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area

Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05269836

Enrollment

Registered

2022-03-08

Start date

2022-03-14

Completion date

2022-11-17

Last updated

2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Surgery, Surgery

Brief summary

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.

Detailed description

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.

Interventions

DEVICESurgify Safety Burr

Use of Surgify Safety Burr in hard tissue cutting, head and spine area

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Disease of the spine or head requiring surgery with bone removal * Ability to understand the purpose and risks of the study and to give written informed consent * Age 18-70 years

Exclusion criteria

* Previous surgery on the same area * Abnormalities of bone tissue * Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation) * Allergy or hypersensitivity to medical-grade stainless steel or any of alloying components * Problems with blood clotting

Design outcomes

Primary

Measure	Time frame	Description
To evaluate usability of SSB	Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.	Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon.
To evaluate safety of SSB	Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.	AE reporting

Secondary

Measure	Time frame	Description
To evaluate effectiveness of SSB	Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.	Using video material from operations, microphone recording of the surgeon commentary during drilling
To evaluate beneficiality of SSB	Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week	Questionnaires to surgeon

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026