NCT06376682

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Quantum Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.

Detailed description

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.

Conditions

• Bone Metastases
• Fractures, Bone
• Bone Tumor

Interventions

Type	Name	Description
PROCEDURE	CT-guided bone percutaneous procedure	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).

Timeline

• Start date: 2024-09-16
• Primary completion: 2024-11-29
• Completion: 2025-01-06
• First posted: 2024-04-19
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

3 sites across 1 country: France