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Surgify Halo™ for Spine Surgery

This study is testing a new medical device called Surgify Halo™ for use in spine surgery. Researchers want to see how easy it is for surgeons to use (usability) and how well it performs compared to a standard drill bit called Rosen Burr. They will also look at how much "chattering" (vibration) the device produces. You may be able to join if you are between 21 and 85 years old, need spine surgery that involves removing bone, and can understand and agree to participate. The study aims to include 30 participants. The main goal is to assess the Surgify Halo™'s usability and performance from the time you enroll until you leave the recovery room after surgery.

Study design
This is an open-label, randomized study comparing Surgify Halo™ to Rosen Burr in 30 participants.
What's involved
You would undergo spine surgery using either the Surgify Halo™ device or the Rosen Burr. Your participation would last from enrollment until the end of your stay in the recovery room.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored from enrollment until the end of your stay in the recovery room after surgery.

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NCT06827795

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
NAAges 21–85Interventional
Surgify Medical Oy
~30 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:A burr used in spine surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
Measured over From enrollment to the end of the surgery until the end of the stay in the recovery room.

Conditions

Spine Surgery

Explore related trials

Spine Surgery

Where it's being run

1 sites across 1 states
New York1

Who to contact

Thanuja Amirthalingam, Study coordinator
[email protected]
516-382-3666
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Usability and performance of the medical device Surgify Halo ™ in revision spine surgeryFrom enrollment to the end of the surgery until the end of the stay in the recovery room.

    Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)