Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
The objectives are: 1. To evaluate the feasibility of the Epione robotic assistance for bone percutaneous procedures. 2. To evaluate the safety and the accuracy of the Epione robotic assistance for bone percutaneous procedures. At least 34 patients (representing at least 67 insertions, as one patient may undergo one or more insertions during the procedure) have been planned for the study. They will be treated by the clinician using the Epione device during a CT-guided percutaneous procedure in musculoskeletal (MSK) structures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures (thermal ablation, bone consolidation, biopsy procedures).
Hospices Civils de Lyon
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Institut Gustave Roussy
Villejuif, France
Successful Introducer Insertion With the EPIONE Device.
To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique
Time frame: Day of the procedure
Adverse Event(s) (AE)
To evaluate the safety of the EPIONE robotic assistance for bone percutaneous procedures: all AEs (serious and non-serious, related and not-related to the device or the procedure(s))
Time frame: Up to 1 month
Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures
To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Lateral deviation: distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory
Time frame: Day of the procedure
Angular Deviation (°)
To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Angular deviation (°): 3D angle between the inserted introducer in its final position and the first planned trajectory.
Time frame: Day of the procedure
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