EPIONE Guided Lung Evaluation (EGLE)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: EPIONE device

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13385
    • Hôpital La Timone
  • Villejuif, France, 94000
    • Gustave Roussy Institut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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 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
Post-intervention ablation success	Minimal Ablation Margin(s) measure(s) (mm) (if aplicable)	through study completion, an average of 1 year
Long-term efficacy of ablation	Evaluation of the local tumor progression following the ablation (if applicable)	through study completion, an average of 1 year
Adverse event	Safety of the device and the procedure	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Quantum Surgical
• Investigators: Principal Investigator: THIERRY DE BAERE, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): August 25, 2023
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Biopsy; Ablation; Robotics; Lung; percutaneous; CT-guided; Abcess Drainage; Fiducial placement
• Other Study ID Numbers: QS-IS-G-H-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No