Recruiting

NCT Number: NCT06827795

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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Spine Surgery

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore University Hospital

New York, 11030, United States

Location status: Recruiting

Location contact

Sheng-fu Larry Lo, Neurosurgeon

PRINCIPAL_INVESTIGATOR

Thanuja Amirthalingam, Study coordinator

CONTACT

[email protected]

516-382-3666

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A burr used in spine surgery

Device

A burr used in spine surgery

Primary outcomes

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.

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)

Sponsors and collaborators

Lead sponsor

Surgify Medical Oy

Industry

Collaborators

North Shore University Hospital

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 14, 2025
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting