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)
Recruiting
N/A
Interventional Study
Spine Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 21 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 30 (estimated)
- Sponsor
- Surgify Medical Oy · Industry
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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 ti…
Trial Locations
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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, Indivi…
Contacts
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