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.

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Spine Surgery
• Intervention / Treatment: Device: Surgify Safety Burr

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • HUS,Töölö hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according to other inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	Questionnaires to surgeon	Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week

Collaborators and Investigators

• Sponsor: Surgify Medical Oy
• Investigators: Principal Investigator: Nuutti Vartiainen, MD, PhD, HUS

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Surgify2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No