Lung Cancer
Conditions
Keywords
percutaneous, CT-guided, Ablation, Biopsy, Abcess Drainage, Fiducial placement, Lung, Robotics
Brief summary
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
Detailed description
The objectives are: * to evaluate the technical success of the device * to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence) * to evaluate the safety of the device 25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device
Interventions
DEVICEEPIONE device
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.
Sponsors
Quantum Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥18 years old, * Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians, * Patient with a signed informed consent form. * Patient covered by a social security system.
Exclusion criteria
* Patient unable to undergo general anesthesia, * Pregnant or nursing female, confirmed before the intervention * Patient already participating in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Device | an average of 7 months | Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Adjustments | an average of 7 months | Detail of the number/nature of adjustments performed after the initial insertion of the needle. |
| Post-intervention Ablation Success | an average of 1 year | If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success |
| Needle Placement Accuracy | an average of 7 months | accuracy of the needle placement: deviation between the planned and actual needle position once inserted. |
| Adverse Event | through study completion, an average of 21 months | number of patients experiencing a serious adverse event |
| Grade of Needle Adjustment | an average of 7 months | Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body) |
| Long-term Efficacy of Ablation | through study completion, an average of 1 year | If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed. We count here the patient treated for which the lesion ablated did not show recurrence after 12 months. |
Countries
France
Participant flow
Recruitment details
25 patients included from 2022-11-30 to 2023-08-25 at the IGR (Villejuif/France).
Participants by arm
| Arm | Count |
|---|---|
| Interventional Arm Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device | 25 |
| Interventional Arm Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | Interventional Arm |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 9.4 |
| Body Mass Index | 25.2 kg/m^2 STANDARD_DEVIATION 4.8 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 8 / 25 |
| serious Total, serious adverse events | 5 / 25 |
Outcome results
Primary
Feasibility of the Device
Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.
Time frame: an average of 7 months
Population: All screened patients who have confirmed their signed informed consent and are planned to be treated using the EPIONE® device.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Interventional Arm | Feasibility of the Device | 26 Number of targets reached |
Secondary
Adverse Event
number of patients experiencing a serious adverse event
Time frame: through study completion, an average of 21 months
Population: all patients included in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Adverse Event | 5 participants |
Secondary
Grade of Needle Adjustment
Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body)
Time frame: an average of 7 months
Population: all patients who started the procedure with EPIONE
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Interventional Arm | Grade of Needle Adjustment | minor adjutsments | 7 needle |
| Interventional Arm | Grade of Needle Adjustment | medium adjustements | 17 needle |
| Interventional Arm | Grade of Needle Adjustment | major adjustements | 1 needle |
| Interventional Arm | Grade of Needle Adjustment | no adjustement | 6 needle |
Secondary
Long-term Efficacy of Ablation
If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed. We count here the patient treated for which the lesion ablated did not show recurrence after 12 months.
Time frame: through study completion, an average of 1 year
Population: all patients whose procedure was feasible and were still in the study after 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Arm | Long-term Efficacy of Ablation | 18 Participants |
Secondary
Needle Placement Accuracy
accuracy of the needle placement: deviation between the planned and actual needle position once inserted.
Time frame: an average of 7 months
Population: all patients whose procedure was feasible
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Arm | Needle Placement Accuracy | 1.2 mm | Standard Deviation 2.1 |
Secondary
Number of Needle Adjustments
Detail of the number/nature of adjustments performed after the initial insertion of the needle.
Time frame: an average of 7 months
Population: all patients whose procedure was feasible
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Arm | Number of Needle Adjustments | 0.8 number of adjustments per needle | Standard Deviation 0.5 |
Secondary
Post-intervention Ablation Success
If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success
Time frame: an average of 1 year
Population: all patients whose procedure was feasible
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Interventional Arm | Post-intervention Ablation Success | 20 lesions |