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)

Part of paid clinical trials in New York, New York.

Sponsor
Surgify Medical Oy
Study ID
NCT06827795
Status
Recruiting
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Conditions

  • Spine Surgery

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • A burr used in spine surgery — DEVICE
    A burr used in spine surgery

Study Details

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 Dates

Start date
Feb 19, 2026
Status verified
Apr 2026
Primary completion
Dec 15, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Surgify Halo
  • Other: State of art Rosen burr

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
North Shore University HospitalNew YorkNew York11030
Thanuja Amirthalingam, Study coordinator
[email protected]
516-382-3666
Sheng-fu Larry Lo, Neurosurgeon (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
North Shore University Hospital· New York, NY

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