N/A
N=34
EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy
Bone Metastases · Fractures, Bone · Bone Tumor
Bottom Line
View on ClinicalTrials.gov: NCT06376682 ↗Enrolled (actual)
34
Serious AEs
11.8%
Results posted
Sep 2025
Primary outcome: Primary: Successful Introducer Insertion With the EPIONE Device. — 89 Successful insertion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT-guided bone percutaneous procedure (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quantum Surgical
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Introducer Insertion With the EPIONE Device. |
89 | — |
| SECONDARY Adverse Event(s) (AE) |
6 | — |
| SECONDARY Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures |
2.00 | — |
| SECONDARY Angular Deviation (°) |
3.06 | — |
Summary
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
Eligibility Criteria
Inclusion Criteria
- 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,
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06376682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.