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Trial Title:
EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy
NCT ID:
NCT06376682
Condition:
Bone Metastases
Fractures, Bone
Bone Tumor
Conditions: Official terms:
Fractures, Bone
Conditions: Keywords:
Robotic
Robotic guidance
Percutaneous
CT-guided
Bone consolidation
Thermal ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The Epione device is an image-guided robotized device that assists the physician during
CT-guided procedures.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
CT-guided bone percutaneous procedure
Description:
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).
Arm group label:
Interventional arm
Summary:
Interventional clinical study to obtain performance and safety data of the EPIONE® device
when used for bone percutaneous procedures.
Criteria for eligibility:
Criteria:
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.
Comment 1: In conventional interventional radiology procedures, pregnancy status is based
on patient declaration.
Comment 2: Patient who has already been included in the EPIBONE study but eligible for
percutaneous procedure of a new musculoskeletal disorder location.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
February 28, 2025
Lead sponsor:
Agency:
Quantum Surgical
Agency class:
Industry
Source:
Quantum Surgical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06376682
