EPIONE Guided Lung Evaluation

Not Applicable

Completed

• Conditions: Lung Cancer

• Registration Number: NCT05651867
• Lead Sponsor: Quantum Surgical

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

Study Timeline

• Study Start: 2022-11-28
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-15
• Primary Completion: 2023-08-25
• Study Completion: 2024-09-10
• Results First Submitted: 2025-05-07
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Results First Posted: 2025-07-15
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Needle Placement Accuracy	an average of 7 months	accuracy of the needle placement: deviation between the planned and actual needle position once inserted.
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
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.
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)

Trial Locations

Locations (1)

Gustave Roussy Institut; 🇫🇷 Villejuif, France