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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)

RecruitingNAAges 21 Years - 85 YearsAllSurgify Medical Oy
NCT06827795 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • A burr used in spine surgery
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Where

1 site
North Shore University Hospital
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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