EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy

Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy

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.

Inclusion Criteria:

1. Patient ≥18 years,
2. Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
3. Patient who has signed an informed consent form,
4. Patient covered by a social security system,

Exclusion Criteria:

1. Patient with contraindication to general anaesthesia,
2. Patient undergoing a procedure without appropriate breathing control,
3. Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
4. Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
5. Pregnant or breast-feeding women,
6. Patient under legal protection (tutorship, guardianship, …),
7. Patient already participating in another interventional clinical study.