Surgify Halo™ versus Rosen burr for cutting performance and usability in spine surgery
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)
NA · Surgify Medical Oy · NCT06827795
This will test whether the Surgify Halo™ device cuts bone with less chattering and better usability than a standard Rosen burr for adults having spine surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Surgify Medical Oy (industry) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06827795 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label, parallel-group comparison enrolling about 30 adult patients undergoing spine surgery that requires bone removal. Participants will be randomly assigned to have bone work performed with the Surgify Halo™ device or with the conventional Rosen burr, and surgeons will record usability and performance metrics during the procedures. Key outcomes include amount of chattering during use, cutting performance, and surgeon-rated usability, with safety monitoring for device-related issues. The device is intended for shaping and removal of hard tissue and bone and will be used in a single-center surgical setting at North Shore University Hospital.
Who should consider this trial
Good fit: Adults aged 21–85 with spine disease requiring surgery with bone removal who can give informed consent are suitable candidates.
Not a fit: Patients with abnormal bone tissue, known allergy to medical-grade stainless steel or alloy components, bleeding or clotting problems, pregnant women, or other excluded vulnerable populations are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the Surgify Halo™ could reduce tool chattering and improve cutting precision and surgeon handling, potentially making certain spine procedures quicker or safer.
How similar studies have performed: Other novel bone-cutting and burr designs have shown mixed results in improving cutting efficiency and surgeon experience, and this specific device has limited comparative published data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- North Shore University Hospital — New York, New York, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spine Surgery