CompletedNot Applicable

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

France34 participantsStarted 2024-09-16

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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,

✕. 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.

Successful Introducer Insertion With the EPIONE Device.

Timeframe: Day of the procedure

NCT IDNCT06376682

SponsorQuantum Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-29

Results submitted2025-08-12