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) (NCT06827795)
π©Ί Plain-English Summary (8th-Grade Level)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo β’ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Haloβ’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.
Who can join: Review the eligibility criteria below.
Location: North Shore University Hospital β New York, New York
Age range: 21 Years to 85 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (1 Sites)
- North Shore University Hospital β New York, New York
π Contact the Study Coordinator
Phone: (516) 382-3666
Email: tamirthalingam@northwell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.