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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)

Surgify Medical Oy · with North Shore University Hospital · NCT06827795

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
February 19, 2026
Record last updated
April 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: A burr used in spine surgery

Conditions: Spine Surgery

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • North Shore University Hospital

    New York, NY 11030

    Site contact: Thanuja Amirthalingam, Study coordinator · 516-382-3666 · tamirthalingam@northwell.edu

An Open, Parallel-group, Randomized, Medical Device Study to… (NCT06827795) | Bored Studies