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•Surgify Medical Oy

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.

Eligibility

Age

21 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

North Shore University Hospital

New York, New York, United States

Key Dates

Start Date

February 19, 2026

Primary Completion Date

December 15, 2026

Completion Date

December 31, 2026

Last Updated

February 18, 2026

Enrollment

ESTIMATED participants

Conditions

Spine Surgery

Interventions

A burr used in spine surgery

DEVICE

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

NCT06020508

Lumbar Spine Surgery

View study

RECRUITINGNA

Irrisept Solution for Instrumented Spine Surgery

NCT06439953

Post-Op ComplicationSpine Surgery+6 more

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Irrisept Solution for Instrumented Spine Surgery

Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery

Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring

Prevalence and Surgical Implications of the Arcuate Foramen: A 3D CT-Based Observational Study

Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients