About this trial
The purpose of this research study is to:
test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).
This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The target is to enroll 30 participants in this study.
Eligibility criteria
Qualifiers
Disease of the spine requiring surgery with bone removal
Ability to understand the purpose and risks of the study and to give written informed consent
Age 21-85 years
Disqualifiers
Abnormalities of bone tissue
Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
Problems with blood clotting
Trial design
Treatments tested in this trial
- A burr used in spine surgery
Treatment groups
Sponsors and collaborators
Surgify Medical Oy
Lead sponsor
North Shore University Hospital
Collaborator