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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)
Sponsor: Surgify Medical Oy
Summary
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in revision 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.
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-02-19
Completion Date
2026-12-31
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
A burr used in spine surgery
A burr used in spine surgery
Locations (1)
North Shore University Hospital
New York, New York, United States