Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs
Phase: NA
Conditions: Lung Cancer
Sponsor: Quantum Surgical

Investigation Number: QS-IS-G-H-2201 
ClinicalTrials.gov ID: NCT05651867 
CIV-ID: 2022-A01812-41 
Doc No: CA-LU-SYN-020-(EN) 
Revision: A
Document title: EGLE Clinical Investigation Synopsis 
 
CATM015-A 
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Page 1 of 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical investigation plan: CA-LU-CIP-0019-Rev3 
 
 
 
 
 
 
 
 
 
 
 
Effective date 
 26-May-2025 
Author name 
Marion CHASSOUANT 
Sponsor 
Quantum Surgical SAS 
1000 rue du Mas de Verchant 
34000 Montpellier 
FRANCE  
Entity funding the study 
Quantum Surgical SAS 
 
 
 
 
CLINICAL INVESTIGATION SYNOPSIS 
 
EGLE study  
 
 
Prospective clinical investigation on the evaluation of performance and safety of the 
EPIONE assisted CT-guided percutaneous procedures in the lungs 

Investigation Number: QS-IS-G-H-2201 
ClinicalTrials.gov ID: NCT05651867 
CIV-ID: 2022-A01812-41 
Doc No: CA-LU-SYN-020-(EN) 
Revision: A
Document title: EGLE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 2 of 5 
Revision History 
Rev. 
Description  
Date  
Author 
A 
Creation of the document in English from CA-LU-CIP-
0019-Rev3 
26-May-2025 
Marion CHASSOUANT 
 
 
Signatures 
Role 
Name 
Date 
Signature 
Clinical Project Leader 
Marion CHASSOUANT 
26-May-2025 
Signed on DocuSign 
Clinical representative 
Silène LAUNAY 
26-May-2025 
Signed on DocuSign 
 
 
 
 
 
 
 
 
 
 
 
 

Investigation Number: QS-IS-G-H-2201 
ClinicalTrials.gov ID: NCT05651867 
CIV-ID: 2022-A01812-41 
Doc No: CA-LU-SYN-020-(EN) 
Revision: A
Document title: EGLE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 3 of 5 
Full study title  
Prospective clinical investigation on the evaluation of performance and safety of the EPIONE 
assisted CT-guided percutaneous procedures in the lungs 
Brief 
study 
title 
EGLE study 
Study design  
Clinical investigation of a CE marked device, used outside of its current indication, for an extension of 
the indication to the lungs.  
Interventional, prospective, non-randomized, non-comparative, single arm study  
Study category
Category 1 according to ANSM categorization 
Study centres 
 
Gustave Roussy Cancer Center 
Therapeutic Imaging Department 
114 rue Edouard Vaillant  
94800 Villejuif  
FRANCE   
Purpose of the 
clinical 
investigation  
The Epione device is a robotic device that assists the physician during CT-guided percutaneous 
treatment. This device is validated in clinical practice for abdomen.  
The aim of this clinical investigation is to confirm in patients the accuracy and safety of the Epione device 
designed to assist radiologists during percutaneous procedures the lungs and thus, extend the Epione 
indication.
Primary 
objective and 
endpoint 
Primary objective: Evaluation of the feasibility of the EPIONE device in assisting needles insertion in 
CT-guided intervention in the lungs.  
 
 
Primary endpoint: The primary feasibility endpoint is the technical success of the intervention per 
lesion.
Secondary 
objectives and 
endpoints 
 
Secondary objectives: 
Evaluation of safety and performance parameters  
 
Secondary criteria:  
Safety  
 
Adverse Event(s) (AE): all AEs (serious and non-serious, including deficiency or dysfunction) and 
AEs related to the device or the intervention. 
 
Performance  
 
Assessment of the needle placement accuracy through an estimation of the distance from the 
needle inserted and the predefined planning;  
 
Assessment of the number and the grade of needle adjustments to achieve technical success;  
 
Assessment of post-intervention ablation success (ablation only);  
 
Assessment of local tumor progression.  
Eligibility 
criteria 
Inclusion criteria
 
Patient ≥18 years, 
 
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.  
 

Investigation Number: QS-IS-G-H-2201 
ClinicalTrials.gov ID: NCT05651867 
CIV-ID: 2022-A01812-41 
Doc No: CA-LU-SYN-020-(EN) 
Revision: A
Document title: EGLE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 4 of 5 
Exclusion criteria
 
Patient unable to undergo general anesthesia,  
 
Pregnant or nursing female, confirmed before the intervention  
 
Patient already participating in another clinical study 
Device 
and 
comparator 
The Epione investigational 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.  
 
The Epione device is composed of 3 main  components (Robot cart, Display cart with software and 
Navigation cart) and 3 instruments (Introducer guide, Patient reference and Navigation probe). 
 
There is no comparator. 
Procedures to 
use the device 
The operating principle of the subject device is the following:  
 
pre-interventional CT-scan acquisition 
 
planning with the device’s software (choice of the needle’s trajectory to reach the targeted 
point) 
 
needle’s insertion according to the predefined planning 
 
acquisition of an per-intervention CT-scan to evaluate the needle(s) placement.  
Study 
flowchart  
Schematic diagram of visit schedule:  
 
 
  
 
 
Visit 1: initial visit – patient screening (D0-1 month) ≤D≤ D0  
Prior to the intervention, interventional radiologists perform a pre-intervention consultation with the 
patient. During the consultation, a review of inclusion and exclusion criteria is performed, presentation 
of the study and the device (oral and printed information for the patient). Paper information notice and 
informed consent forms are read and given to the patient with sufficient time to consider the study’s 
implications before deciding whether to participate. Next visit planned (day of the CT-guided 
intervention).  
 
 
Visit 2: inclusion visit –Day of the intervention D0  
Retrieval of the signed informed consent form by the investigator (signed by the patient and the 
investigator), confirmation of enrollment and validation of screening (inclusion and non-inclusion 
criteria are confirmed), demographic data, tumor data, primary cancer data as well as other medical 
history. Collection of concomitants pathologies/treatments.  

Investigation Number: QS-IS-G-H-2201 
ClinicalTrials.gov ID: NCT05651867 
CIV-ID: 2022-A01812-41 
Doc No: CA-LU-SYN-020-(EN) 
Revision: A
Document title: EGLE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 5 of 5 
Patient placed under general anesthesia. Acquisition of the pre-intervention CT-guided image of the 
lungs. Confirmation of the prescribed CT-guided intervention realization (if the intervention is not 
maintained, the patient's exit from the study, for screening failure). Planning with the subject device to 
visualize the path of needle(s) to the target. Planning validation by the investigator and then insertion 
of the needle(s) to the targeted area with the subject device. Acquisition of the per-intervention image 
under CT guidance. Validation of the correct positioning of the needle(s). Completion of the CT-guided 
intervention with a needle routinely used by the investigator. Acquisition of the post-intervention CT-
guided image and evaluation of possible adverse events. in case of interventions on multiple lesions, 
the absence of a non-reduced major pneumothorax must be confirmed to use the device again for the 
next intervention. In case of interventions performed on different days on or both lungs treated on two 
different days, the additional intervention day will be added to the D0 sheet.  
 
 
Visit 3: post-intervention follow-up visit at 1 month (D0+2 weeks ≤ D ≤ D0+6 weeks)  
Follow-up of AEs related to the intervention and record of possible new AE/SAEs.  
Review of the acquired image (CT-scan or equivalent) of the lungs to evaluate for ablation the ablation 
site local tumor progression and establish a baseline situation of the treated tumor.  
 
 
Visit 4: post-intervention follow-up visit at 6 months (D0+4 months ≤ D ≤ D0+8 months) 
Review of the acquired image (CT-scan or equivalent) of the lungs to evaluate ablation site local tumor 
progression and evaluation of possible AE/SAEs. 
 
 
Visit 5: post-intervention follow-up visit at 12 months (D0+10 months ≤ D ≤D0+14 
months)  
Review of the acquired image (CT-scan or equivalent) of the lungs to evaluate ablation site, local tumor 
progression and evaluation of possible AE/SAEs.  
Sample size  
25 patients 
Randomisation 
and blinding 
Not applicable. 
Statistical 
analysis 
method 
The statistical analysis will be performed by an external CRO (Delta Data Consultants, Eybens, France). 
All statistical analyses will be produced using SAS® 9.4 software (Cary, NC, USA).). 
Study duration 
per patient  
From patient’s informed consent form signature to visit 5.  
From 10 months to 15 months, depending on the day of patient’s signed informed consent retrieval 
and the day of the visit 5:  
 
10 months if the patient informed consent form is collected the day of the intervention, and the 
last visit is performed at the beginning of the time window (10 months)  
 
15 months if the patient informed consent form is collected at the initial visit 1 month before 
the intervention, and the last visit performed at the end of the time window (15 months)  
Study schedule
Planned start: October 2022  
Planned recruitment time: 6 months  
Planned last patient out: Q1 2024