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

Not Applicable

Completed

• Conditions: Bone Metastases; Bone Tumor; Fractures, Bone

• Registration Number: NCT06376682
• Lead Sponsor: Quantum Surgical

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-19
• Study Start: 2024-09-16
• Primary Completion: 2024-11-29
• Study Completion: 2025-01-06
• Results First Submitted: 2025-08-12
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Results First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Successful Introducer Insertion With the EPIONE Device.	Day of the procedure	To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique

Secondary Outcome Measures

Name	Time	Method
Adverse Event(s) (AE)	Up to 1 month	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))
Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures	Day of the procedure	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
Angular Deviation (°)	Day of the procedure	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.

Trial Locations

Locations (3)

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France