EPIONE Guided Lung Evaluation

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: EPIONE device

• 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
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

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

Arm && Interventions

Group	Intervention	Description
Interventional arm	EPIONE device	Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device

Primary Outcome Measures

Name	Time	Method
Feasibility of the device	an average of 7 months	Number of targets reached ; the target is considered reached when the needle is positioned accurately enough 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 and grade 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	through study completion, an average of 1 year	Minimal Ablation Margin(s) measure(s) (mm) (if aplicable)
Long-term efficacy of ablation	through study completion, an average of 1 year	Evaluation of the local tumor progression following the ablation (if applicable)
Adverse event	through study completion, an average of 1 year	Safety of the device and the procedure

Trial Locations

Locations (1)

Gustave Roussy Institut; 🇫🇷 Villejuif, France