Status:
COMPLETED
Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area
Lead Sponsor:
Surgify Medical Oy
Conditions:
Spine Surgery
Surgery
Eligibility:
All Genders
18-70 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05269836
Start Date
March 14 2022
End Date
November 17 2022
Last Update
November 30 2022
Active Locations (1)
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1
HUS,Töölö hospital
Helsinki, Finland, 00290