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

Philips Medical Systems Nederland B.V.0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•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

•-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.

发起方