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

Bone Metastases Clinical Trial

— EPIBONE  

Official title:

Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376682
• Other study ID #: CA-BO-CIP-0060
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Quantum Surgical
• Contact: Laetitia P Messner
• Phone: 0448194050
• Email: l.messner[@]quantumsurgical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

5. Patient who has already been included in the EPIBONE study but eligible for percutaneous procedure of a new musculoskeletal disorder location.

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. In conventional interventional radiology procedures, pregnancy status is based on patient declaration.

Related Conditions & MeSH terms

• Bone Metastases
• Bone Tumor
• Fractures, Bone

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quantum Surgical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful instrument insertion with the EPIONE device.	Assessment of the feasibility of the EPIONE robotic system assistance for bone percutaneous procedures based on a definition of conversion to manual technique	During procedure