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)

Not Applicable

Not yet recruiting

• Conditions: Spine Surgery

• Registration Number: NCT06827795
• Lead Sponsor: Surgify Medical Oy

Brief Summary

The purpose of this research study is to:

test the usability and performance of the medical device Surgify Halo ™ in revision 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Start: 2025-06-30
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Disease of the spine or head 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

• Previous surgery in the same area

  • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery	From enrollment to the end of the surgery until the end of the stay in the recovery room.	Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 New York City, New York, United States