Recruiting

Surgify Halo

Sponsor:

Surgify Medical Oy

Code:

NCT06827795

Conditions

Spine Surgery

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

A burr used in spine surgery

Study Details

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

Study ID

NCT06827795

Start date

Feb 19, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Surgify Halo

other: State of art Rosen burr

Interventions

A burr used in spine surgery

A burr used in spine surgery

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. ]

Central Contacts and Locations

Locations

North Shore University Hospital

Recruiting

New York, New York, United States, 11030

Contacts

Thanuja Amirthalingam, Study coordinator

516-382-3666tamirthalingam@northwell.edu

Principal Investigator:

Sheng-fu Larry Lo, Neurosurgeon

More Information

Sponsor

Surgify Medical Oy

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Surgify Medical Oy on 2026-04-30.