An interventional study of EPIONE device in Lung Cancer, sponsored by Quantum Surgical. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Quantum Surgical · Not applicable, Interventional, and Treatment
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
The objectives are:
to evaluate the safety of the device
25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Quantum Surgical is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device
Device: EPIONE 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.
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
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
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
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
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
Adverse Event
number of patients experiencing a serious adverse event
Time frame: through study completion, an average of 21 months
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
25 patients included from 2022-11-30 to 2023-08-25 at the IGR (Villejuif/France).
| Milestone | Interventional Arm |
|---|---|
| Started | 25 |
| Completed | 19 |
| Not completed | 6 |
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.
| Number of targets reached | Interventional Arm |
|---|---|
| Feasibility of the Device | 26 |
accuracy of the needle placement: deviation between the planned and actual needle position once inserted.
| mm | Interventional Arm |
|---|---|
| Needle Placement Accuracy | 1.2 ± 2.1 |
Detail of the number/nature of adjustments performed after the initial insertion of the needle.
| number of adjustments per needle | Interventional Arm |
|---|---|
| Number of Needle Adjustments | 0.8 ± 0.5 |
If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success
| lesions | Interventional Arm |
|---|---|
| Post-intervention Ablation Success | 20 |
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.
| Participants | Interventional Arm |
|---|---|
| Long-term Efficacy of Ablation | 18 |
number of patients experiencing a serious adverse event
| participants | Interventional Arm |
|---|---|
| Adverse Event | 5 |
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)
| needle | Interventional Arm |
|---|---|
| minor adjutsments | 7 |
| medium adjustements | 17 |
| major adjustements | 1 |
| no adjustement | 6 |
Collected over through study completion, an average of 21 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional Arm | 0/25 (0%) | 5/25 (20%) | 8/25 (32%) |
| Event | Interventional Arm |
|---|---|
| PNEUMOTHORAXRespiratory, thoracic and mediastinal disorders | 4/25 |
| ABCESSInfections and infestations | 1/25 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/25 |
| pneumapathyRespiratory, thoracic and mediastinal disorders | 1/25 |
| Event | Interventional Arm |
|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 6/25 |
| HaemorrhageVascular disorders | 2/25 |
number of lesions treated with the Epione device
| Age, Continuous(years) | Interventional Arm |
|---|---|
| Mean | 64.2 ± 9.4 |
| Sex: Female, Male(Participants) | Interventional Arm |
|---|---|
| Female | 7 |
| Male | 18 |
| Race and Ethnicity Not Collected(Participants) | Interventional Arm |
|---|
| Body Mass Index(kg/m^2) | Interventional Arm |
|---|---|
| Mean | 25.2 ± 4.8 |
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