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

NCT06376682 | Completed Results DMC

• 1 other identifier: CA-BO-CIP-0060
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Bone Metastases; Fractures, Bone; Bone Tumor

Keywords

Robotic; Robotic guidance; Percutaneous; CT-guided; Bone consolidation; Thermal ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse Event(s) (AE)

  Up to 1 month

• Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures

  Day of the procedure

• Angular Deviation (°)

  Day of the procedure

Study Arms (1)

Interventional arm

EXPERIMENTAL

Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device

Procedure: CT-guided bone percutaneous procedure

Interventions

CT-guided bone percutaneous procedure 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).

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient with contraindication to general anaesthesia,
• Patient undergoing a procedure without appropriate breathing control,
• Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
• 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.
• Pregnant or breast-feeding women,
• Patient under legal protection (tutorship, guardianship, …),
• Patient already participating in another interventional clinical study.

Sponsors & Collaborators

• Quantum Surgical: lead
• ICUREsearch: collaborator

Study Sites (3)

Hospices Civils de Lyon

Lyon, 69000, France

Location

Institut Paoli-Calmettes

Marseille, 13000, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Fractures, Bone; Bone Neoplasms

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: MESSNER Laetitia, Chief Clinical officer
• Organization: quantum surgical

clinical.department@quantumsurgical.com

+33 (0) 4 48 19 40 50

Study Officials

• Baptiste BONNET

  Gustave Roussy Cancer Institute

  PRINCIPAL INVESTIGATOR

• Nicolas STACOFFE

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Gilles PIANA

  Paoli-Calmettes Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 19, 2024
• Study Start: September 16, 2024
• Primary Completion: November 29, 2024
• Study Completion: January 6, 2025
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)