Bone Metastases, Bone Tumor, Fractures, Bone
Conditions
Keywords
Robotic, Robotic guidance, Percutaneous, CT-guided, Bone consolidation, Thermal ablation
Brief summary
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
Detailed description
The objectives are: 1. To evaluate the feasibility of the Epione robotic assistance for bone percutaneous procedures. 2. To evaluate the safety and the accuracy of the Epione robotic assistance for bone percutaneous procedures. At least 34 patients (representing at least 67 insertions, as one patient may undergo one or more insertions during the procedure) have been planned for the study. They will be treated by the clinician using the Epione device during a CT-guided percutaneous procedure in musculoskeletal (MSK) structures.
Interventions
PROCEDURECT-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).
Sponsors
ICUREsearch
Quantum Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Introducer Insertion With the EPIONE Device. | Day of the procedure | To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event(s) (AE) | Up to 1 month | To evaluate the safety of the EPIONE robotic assistance for bone percutaneous procedures: all AEs (serious and non-serious, related and not-related to the device or the procedure(s)) |
| Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures | Day of the procedure | To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Lateral deviation: distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory |
| Angular Deviation (°) | Day of the procedure | To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Angular deviation (°): 3D angle between the inserted introducer in its final position and the first planned trajectory. |
Countries
France
Participant flow
Recruitment details
Enrollment occurred bewteen 16-SEP-2024 and 29-NOV-2024 in the 3 sites. Across the 34 patients included, 90 CT-guided insertions were performed (mean of 2.6 insertions per patient (range: 1-7)).
Participants by arm
| Arm | Count |
|---|---|
| Interventional Arm Patients treated by CT-guided percutaneous procedures in the bone with the EPIONE® device | 34 |
| Interventional Arm Patients treated by CT-guided percutaneous procedures in the bone with the EPIONE® device | 90 |
| Total | 124 |
Baseline characteristics
| Characteristic | Interventional Arm |
|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 14.5 |
| Body Mass Index | 24.4 Kg/m^2 STANDARD_DEVIATION 4.4 |
| Region of Enrollment France | 34 participants |
| Sex: Female, Male Patients Female | 20 Participants |
| Sex: Female, Male Patients Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 34 |
| other Total, other adverse events | 3 / 34 |
| serious Total, serious adverse events | 4 / 34 |
Outcome results
Primary
Successful Introducer Insertion With the EPIONE Device.
To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique
Time frame: Day of the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Successful Introducer Insertion With the EPIONE Device. | 89 Successful insertion |
Secondary
Adverse Event(s) (AE)
To evaluate the safety of the EPIONE robotic assistance for bone percutaneous procedures: all AEs (serious and non-serious, related and not-related to the device or the procedure(s))
Time frame: Up to 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Arm | Adverse Event(s) (AE) | 6 Participants |
Secondary
Angular Deviation (°)
To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Angular deviation (°): 3D angle between the inserted introducer in its final position and the first planned trajectory.
Time frame: Day of the procedure
Population: Accuracy was measured by insertion. A patient could have multiple introducer insertions during his procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Arm | Angular Deviation (°) | 3.06 ° | Standard Deviation 2.74 |
Secondary
Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures
To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Lateral deviation: distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory
Time frame: Day of the procedure
Population: Accuracy was measured by insertion. A patient could have multiple introducer insertions during his procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Arm | Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures | 2.00 mm | Standard Deviation 1.41 |