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

Completed

• Conditions: Spine Surgery; Surgery

• Registration Number: NCT05269836
• Lead Sponsor: Surgify Medical Oy

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.

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Study Start: 2022-03-14
• Primary Completion: 2022-10-13
• Status Verified: 2022-11
• Study Completion: 2022-11-17
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

HUS,Töölö hospital; 🇫🇮 Helsinki, Finland