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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269836
• Other study ID #: Surgify2021
• Status: Completed
• Start date: March 14, 2022
• Est. completion date: November 17, 2022

Study information

• Verified date: November 2022
• Source: Surgify Medical Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 17, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery
• Surgery

Intervention

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

Locations

Country	Name	City	State
Finland	HUS,Töölö hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Surgify Medical Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.
Secondary	To evaluate beneficiality of SSB	Questionnaires to surgeon	Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week