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)

Launched by SURGIFY MEDICAL OY · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called Surgify Halo™ to see how well it works in spine surgery compared to a commonly used tool known as the Rosen burr. The main goals are to evaluate how easy the Surgify Halo™ is to use and how effectively it cuts through bone during surgery. The researchers plan to enroll 30 participants who need surgery on their spine or head that involves removing bone.

To be eligible for this study, participants should be between the ages of 21 and 85 and must have a condition that requires surgical treatment involving bone removal. They also need to be able to understand and agree to the study's purpose and risks. However, people who have had previous surgery in the area being treated, have certain bone conditions, or are in vulnerable situations (like being pregnant or having difficulty making decisions) cannot participate. If you join the study, you can expect to help researchers learn more about this new device, which could improve spine surgery in the future.

Gender

ALL

Eligibility criteria

• 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