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)

Recruiting now · Not applicable

Conditions studied: Spine Surgery

In brief

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.

Key facts

Study ID

NCT06827795

Run by

Surgify Medical Oy

People needed

30

Starts

2026-02-19

Expected to finish

2026-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 it is running

• North Shore University Hospital — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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