NL-OMON24700
Completed
N/A
Prospective clinical study with Surgical Navigation Release 1.5 and Bone Access Trackable Needle to plan, position and check instrument placement for percutaneous spine surgery
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Philips Medical Systems Nederland B.V.
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject will be undergoing a percutaneous spine surgery with thoracolumbar sacral pedicle screw placement in a maximum of 4 levels to stabilize the spine for spine pathologies like spondylolisthesis, spondylolysis, stenosis, fractures, tumors, disc herniation.
- •\-Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law
Exclusion Criteria
- •\-Subject participates in a potentially confounding drug\- or device trial during the course of the study.
- •\-All vulnerable subjects such as adults lacking the capacity to provide consent, patients in emergency situations, pregnant or breast feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any
- •\-All subjects who are employees of the parties involved in the study
- •\-The distance between the skin entry point and the position of the Bone access needle tip inside the pedicle should not exceed 108 mm as this may obscure the tracking marker on the needle shaft, potentially causing failure of device tracking functionality.
Outcomes
Primary Outcomes
Not specified
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