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

Not Applicable

Active, not recruiting

• Conditions: Bone Metastases; Bone Tumor; Fractures, Bone
• Interventions: Procedure: CT-guided bone percutaneous procedure

• 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

Not available

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
• Status Verified: 2024-11
• Primary Completion: 2024-11-29
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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,

Non-inclusion 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	CT-guided bone percutaneous procedure	Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device

Primary Outcome Measures

Name	Time	Method
Successful instrument insertion with the EPIONE device.	During procedure	Assessment of the feasibility of the EPIONE robotic system assistance for bone percutaneous procedures based on a definition of conversion to manual technique

Secondary Outcome Measures

Name	Time	Method
Safety of the EPIONE robotic assistance for bone percutaneous procedures	During the procedure and up to the 1-month follow-up visit	Adverse event(s) (AE): all AEs (serious and non-serious, related and not-related to the device or the procedure(s))
Accuracy of the EPIONE robotic assistance for bone percutaneous procedures	During procedure	Lateral and angular deviations

Trial Locations

Locations (3)

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France