NCT06827795NARecruiting
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
Surgify Medical Oy
Start Date
2/19/2026
Completion Date
12/31/2026
Summary
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
Age Range: 21 years to 85 years
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Interventions
DEVICE
A burr used in spine surgery
Conditions
Spine Surgery
Locations
North Shore University Hospital
New York, New York 11030
United States