Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen
Conditions: Cancer Abdomen
Sponsor: Quantum Surgical

ID RCB : not applicable 
Sponsor ID : QS-NIS-G-H-2101 
Title of document : Protocol synopsis 
 
Date: 03-OCT-2022 
Version: 2.0 
 
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POST MARKET FOLLOW-UP STUDY OF A ROBOTIC DEVICE FOR IMAGE-
GUIDED PERCUTANEOUS NEEDLE PLACEMENT IN THE ABDOMEN 
 
 
 
 
Study title 
Post Market Clinical Follow-up study of a robotic device for image-guided 
percutaneous needle placement in the abdomen 
Study Number 
QS-NIS-G-H-2101 
Investigational 
product 
EPIONE® device  
Investigational 
product 
characteristics 
The device is a user controlled, stereotactic accessory intended to assist 
in the planning and manual advancement of needle, as well as in 
verification of needle position during CT-guided percutaneous ablation 
procedures.  
Investigational device 
administration 
The operating principle of the investigational device is the following: pre-
interventional CT-scan acquisition, planning with the device’s software , 
needle’s insertion according to the predefined planning, acquisition of a 
per-procedure CT-scan to evaluate the needle(s) placement. 
Reference 
therapy/product
N/A 
Study design 
Post Market Clinical Follow-up study (PMCF) 
Non-interventional, prospective, non-comparative study 
Number of sites & 
country 
1 site in France 
Sample size 
Around 55 patients 
Around 55 CT-guided procedures in the abdomen  
Indication 
Percutaneous CT-guided procedures (tumor ablation, biopsy, …) in the 
abdomen (liver, kidney, …) 

ID RCB : not applicable 
Sponsor ID : QS-NIS-G-H-2101 
Title of document : Protocol synopsis 
 
Date: 03-OCT-2022 
Version: 2.0 
 
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This document is Confidential and Proprietary of Quantum Surgical and unauthorized use is prohibited.  
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Primary objective 
Evaluation of the technical success of the device
Primary endpoint 
Number of targets reached; the target is considered to have been reached 
when the needle is positioned accurately enough to allow the planned 
procedure to be performed. 
Secondary 
objective 
Assessment of performance parameters and safety 
Secondary 
endpoint 
Performance parameters  
o Assessment of the needle placement accuracy  
o Assessment of the needle adjustments to reach the target 
o Assessment of post-intervention ablation success   
o Assessment of local tumor recurrence, 
o Operator satisfaction through a 5-points Likert scale question 
o Device dysfunction 
 
Safety 
o Adverse Event(s) (AEs) 
Patient 
inclusion/exclusion 
criteria 
Inclusion criteria: 
1. Patient is >18 years old, 
2. Patient for whom a CT-guided procedure in abdomen has been 
prescribed and agreed by a multidisciplinary team of radiologists, 
surgeons and clinicians, 
3. Patient with a confirmed non-opposition. 
Exclusion criteria:  
1. Patient unable to undergo general anesthesia, 
Pregnant or breast-feeding female 
Visit schedule 
Schematic diagram of visit schedule:  
 
 
Visit 1: initial visit – patient screening 
(D0-1 month) ≤D≤D0 
Review of inclusion and exclusion criteria, presentation of the study and the 
device (oral and written information for the patient). Paper information 

ID RCB : not applicable 
Sponsor ID : QS-NIS-G-H-2101 
Title of document : Protocol synopsis 
 
Date: 03-OCT-2022 
Version: 2.0 
 
CATMWO-A     
This document is Confidential and Proprietary of Quantum Surgical and unauthorized use is prohibited.  
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This document is considered uncontrolled unless “Copy” stamped by the Quality Department 
 
notice and non-opposition forms discussed with the patient allowing them 
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 – procedure day 
D0 
- 
Confirmation of the non-opposition by the investigator, 
- 
Collection of demographic data, tumor data, primary cancer data as 
well as other medical history. Collection of concomitants 
pathologies/treatments.  
- 
Patient placed under general anesthesia.  
- 
Acquisition of the pre-interventional CT-guided image for the 
planning phase.  
- 
Insertion of the needle(s) to the targeted area with the subject device. 
- 
Acquisition of the per-procedure image under CT guidance. 
- 
Validation of the correct positioning of the needle(s).  
- 
Acquisition of the post-interventional CT-guided image.  
 
 
Visit 3: post-intervention follow-up visit at 2 months 
(D0+3 weeks≤D≤D0+3 months) 
Acquisition of an image (CT-guided or MRI) of the organ to evaluate ablation 
site recurrence (local tumor recurrence) and possible AEs.  
 
 
Visit 4: post-intervention follow-up visit at 10 months 
(D0+6 months≤D≤D0+15 months) 
Acquisition of an image (CT-guided or MRI) of the organ to evaluate ablation 
site recurrence (local tumor recurrence) and possible AEs. 
Study duration per 
patient 
From patient’s information and non-opposition form signature to visit 4.  
From 6 months to 16 months, depending on the day of patient’s non-
opposition confirmation and the day of the visit 4. 
Study schedule 
Planned start:                         Q1 2022 
Planned recruitment time:     18 months 
Planned last patient out:        Q1 2024 
Randomization/ 
blinding
No randomization, open label 
DSMB 
Non 
GCP statement 
This study will be conducted in compliance with the protocol, the current 
version of the Declaration of Helsinki, the ICH-GCP and ISO EN 14155 as well 
as all national legal and regulatory requirements.