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)

Surgify Medical

Status

Not yet enrolling

Conditions

Spine Surgery

Treatments

Device: A burr used in spine surgery

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06827795

Pro00079896

Details and patient eligibility

About

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 atraumatic shaping and removal of hard tissue and bone in neurosurgical (Cranial, Craniofacial), spinal, ear, and general surgical procedures. The target is to enroll 30 participants in this study.

Enrollment

30 estimated patients

Sex

All

Ages

21 to 85 years old

Volunteers

No 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