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 | Recruiting FDA Device

• 1 other identifier: Pro00079896
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Usability and performance of the medical device Surgify Halo ™ in revision spine surgery

  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)

  From enrollment to the end of the surgery until the end of the stay in the recovery room.

Study Arms (2)

Surgify Halo

OTHER

Device: A burr used in spine surgery

State of art Rosen burr

OTHER

Device: A burr used in spine surgery

Interventions

A burr used in spine surgery DEVICE

A burr used in spine surgery

State of art Rosen burr; Surgify Halo

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Surgify Medical Oy: lead
• North Shore University Hospital: collaborator

Study Sites (1)

North Shore University Hospital

New York, New York, 11030, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 14, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)