EPIONE Guided Lung Evaluation

Lung Cancer Clinical Trial

— EGLE  

Official title:

Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05651867
• Other study ID #: QS-IS-G-H-2201
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: September 2023
• Source: Quantum Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: August 30, 2024
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital La Timone	Marseille
France	Gustave Roussy Institut	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Quantum Surgical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the device	Number of targets reached ; the target is considered reached when the needle is positioned accurately enough to allow the planned procedure to be performed.	an average of 7 months
Secondary	Needle placement accuracy	accuracy of the needle placement: deviation between the planned and actual needle position once inserted.	an average of 7 months
Secondary	Number and grade of needle adjustments	Detail of the number/nature of adjustments performed after the initial insertion of the needle.	an average of 7 months
Secondary	Post-intervention ablation success	Minimal Ablation Margin(s) measure(s) (mm) (if aplicable)	through study completion, an average of 1 year
Secondary	Long-term efficacy of ablation	Evaluation of the local tumor progression following the ablation (if applicable)	through study completion, an average of 1 year
Secondary	Adverse event	Safety of the device and the procedure	through study completion, an average of 1 year