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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPIONE device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | an average of 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Needle Placement Accuracy | accuracy of the needle placement: deviation between the planned and actual needle position once inserted. | an average of 7 months |
| Number of Needle Adjustments | Detail of the number/nature of adjustments performed after the initial insertion of the needle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baptiste BONNET, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Institut | Villejuif | 94000 | France |
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25 patients included from 2022-11-30 to 2023-08-25 at the IGR (Villejuif/France).
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Arm | Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
number of lesions treated with the Epione device
| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Arm | Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All screened patients who have confirmed their signed informed consent and are planned to be treated using the EPIONE® device. | Posted | Count of Units | Number of targets reached | an average of 7 months | Number of targets reached | Number of targets reached |
|
through study completion, an average of 21 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Arm | Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marion Chassouant | Quantum Surgical | 0033781425198 | m.chassouant@quantumsurgical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2025 | Jun 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2023 | May 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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 | 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. | through study completion, an average of 1 year |
| Adverse Event | number of patients experiencing a serious adverse event | 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) | an average of 7 months |
| lesions |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 | Participants |
|
|
|
|
| Secondary | Needle Placement Accuracy | accuracy of the needle placement: deviation between the planned and actual needle position once inserted. | all patients whose procedure was feasible | Posted | Mean | Standard Deviation | mm | an average of 7 months | needles | needles |
|
|
|
| Secondary | Number of Needle Adjustments | Detail of the number/nature of adjustments performed after the initial insertion of the needle. | all patients whose procedure was feasible | Posted | Mean | Standard Deviation | number of adjustments per needle | an average of 7 months | needle | needle |
|
|
|
| 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 | all patients whose procedure was feasible | Posted | Count of Units | lesions | an average of 1 year | lesions | lesions |
|
|
|
| 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. | all patients whose procedure was feasible and were still in the study after 12 months | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
|
| Secondary | Adverse Event | number of patients experiencing a serious adverse event | all patients included in the study | Posted | Number | participants | through study completion, an average of 21 months |
|
|
|
| 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) | all patients who started the procedure with EPIONE | Posted | Count of Units | needle | an average of 7 months | needle | needle |
|
|
|
| 0 |
| 25 |
| 5 |
| 25 |
| 8 |
| 25 |
| ABCESS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pneumapathy | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| no adjustement |
|