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

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Bone Metastases; Bone Tumor
• Intervention / Treatment: Procedure: CT-guided bone percutaneous procedure

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • Hospices Civils de Lyon
  • Marseille, France, 13000
    • Institut Paoli-Calmettes
  • Villejuif, France, 94800
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))	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	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.	Day of the procedure

Collaborators and Investigators

• Sponsor: Quantum Surgical
• Collaborators: ICUREsearch
• Investigators: Principal Investigator: Baptiste BONNET, Gustave Roussy Cancer Institute; Principal Investigator: Nicolas STACOFFE, Hospices Civils de Lyon; Principal Investigator: Gilles PIANA, Paoli-Calmettes Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Thermal ablation; Robotic; Percutaneous; CT-guided; Bone consolidation; Robotic guidance
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Fractures, Bone; Bone Neoplasms
• Other Study ID Numbers: CA-BO-CIP-0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No