Actively Recruiting
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)
Led by Surgify Medical Oy · Updated on 2026-04-30
30
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
S
Surgify Medical Oy
Lead Sponsor
N
North Shore University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Abnormalities of bone tissue
- Vulnerable patients such as prisoners, individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, emergency patients, and pregnant women
- Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
- Problems with blood clotting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
North Shore University Hospital
New York, New York, United States, 11030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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