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)

ConditionSpine Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorSurgify Medical Oy

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • A burr used in spine surgery

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Surgify Medical Oy

Lead sponsor

North Shore University Hospital

Collaborator