An Open, Parallel-group, Randomized Medical Device Study to Assess the Usability and Performance of Surgify HaloTM Versus Rosen Burr in Spine Surgery

What this Trial Is About

Researchers are evaluating the usability and performance of the Surgify Halo™ medical device in spine surgery. The study aims to compare the device's cutting performance and level of "chattering" during use with the commonly used Rosen burr drill bit. This device is designed for shaping and removing hard tissue and bone in various surgical procedures, including neurosurgical, spinal, ENT, and general surgeries. The study plans to enroll 30 participants who require spine surgery involving bone removal. Participants will be randomly assigned to use either the Surgify Halo™ device or the state-of-the-art Rosen burr during their spine surgery. The study is open-label, meaning neither participants nor researchers are blinded to the treatment groups. The evaluation will focus on the performance of the device from enrollment through the surgery and continue until the patient leaves the recovery room. During the study, researchers will closely monitor how well the Surgify Halo™ performs compared to the Rosen burr, paying special attention to usability and cutting efficiency. The primary outcome measure is the device's usability and performance throughout the surgery and recovery stay. Participants will be assessed during the procedure, and recovery progress will be observed until discharge from the recovery room. The total study duration for each participant covers the surgical treatment and immediate postoperative recovery period.

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)