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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A burr used in spine surgery.
- Who it may be relevant to
- Registry conditions: Spine Surgery. Basic parameters: 21 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device A burr used in spine surgery
A burr used in spine surgery
Primary outcome measures
- Usability and performance of the medical device Surgify Halo ™ in revision spine surgery [Time frame: From enrollment to the end of the surgery until the end of the stay in the recovery room.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- North Shore University Hospital — New York
Identifiers
NCT: NCT06827795 · Pro00079896