NCT06827795 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)
| NCT ID | NCT06827795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Surgify Medical Oy |
| Condition | Spine Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-02-19 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT06827795 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Spine Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06827795 currently recruiting?
Yes, NCT06827795 is actively recruiting participants. Visit ClinicalTrials.gov or contact Surgify Medical Oy to inquire about joining.
Where is the NCT06827795 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06827795 clinical trial?
NCT06827795 is sponsored by Surgify Medical Oy. The trial plans to enroll 30 participants.