Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy
Phase: NA
Conditions: Bone Metastases, Fractures, Bone, Bone Tumor
Sponsor: Quantum Surgical

Investigation Number: EPIBONE 
ClinicalTrials.gov ID: 
CIV-ID: 2024-A00468-39 
 
Doc No: CA-BO-SYN-0053 
Revision: B 
Document title: EPIBONE Clinical Investigation Synopsis 
 
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Page 1 of 6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical investigation plan: CA-BO-CIP-0060 
 
 
 
 
 
 
 
 
 
 
 
Effective date 
05-JUN-2024  
Author name 
Silène LAUNAY 
Sponsor 
Quantum Surgical SAS 
1000 rue du Mas de Verchant 
34000 Montpellier 
FRANCE  
Entity funding the study 
Quantum Surgical SAS 
 
 
 
 
CLINICAL INVESTIGATION SYNOPSIS 
 
EPIBONE study  
 
Evaluation of the EPIONE robotic system for image-guided percutaneous bone procedures 
A prospective study on feasibility, safety and accuracy 

Investigation Number: EPIBONE 
ClinicalTrials.gov ID: 
CIV-ID: 2024-A00468-39 
 
Doc No: CA-BO-SYN-0053 
Revision: B 
Document title: EPIBONE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 2 of 6 
Revision History 
Rev. 
Description  
Date  
Author 
A 
Creation of the document 
16-JUL-2024 
Silène LAUNAY 
B 
Protocol amendment including:   
- Deletion of eligibility criterion number 5    
- Addition of a note on eligibility criteria  
08-OCT-2024 
Silène LAUNAY 
 
 
Signatures 
Role 
Name/Nom 
Date 
Signature 
Clinical Project Leader 
Silène LAUNAY 
 
 
Clinical Chief Operator 
Laetitia MESSNER 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
08-OCT-24
08-OCT-24

Investigation Number: EPIBONE 
ClinicalTrials.gov ID: 
CIV-ID: 2024-A00468-39 
 
Doc No: CA-BO-SYN-0053 
Revision: B 
Document title: EPIBONE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 3 of 6 
Full study title /  
Titre complet de l’étude 
Evaluation of the Epione robotic system for image-guided percutaneous bone 
procedures 
A prospective study on feasibility, safety and accuracy 
Brief study title 
Titre abrégé de l’étude 
EPIBONE study 
Study design / 
Design de l’étude 
Multicentric, prospective, non-comparative study 
Study category /  
Catégorie de l’étude 
Category 1 according to ANSM categorization 
Study centres /  
Centres investigateurs 
Gustave Roussy Cancer Center 
Therapeutic Imaging Department 
114 rue Edouard Vaillant  
94800 Villejuif  
FRANCE   
 
HCL Hospices Civils de Lyon   
Medical Imaging Department 
Quai Celestins   
69002 Lyon  
FRANCE   
 
Institut Paoli Calmette 
Medical Imaging Department 
232 Boulevard de Sainte-Marguerite 
13009 Marseille 
FRANCE   
Purpose of the clinical 
investigation / 
Objectif de l’investigation 
clinique 
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 and 
lung. The state of the art in percutaneous bone procedures and the observation of 
current practices highlighted the need to explore the use of the Epione device in this 
new indication.  
The aim of this clinical investigation is to confirm in patients the performance and safety 
of the Epione device designed to assist radiologists during percutaneous procedures in 
musculo-skeletal structures in view of the satisfactory results obtained during 
preclinical tests.  
Primary 
objective 
and 
endpoint /  
Objectif 
et 
critère 
d’évaluation primaire 
Primary objective: Evaluate the feasibility of the Epione robotic assistance for bone 
percutaneous procedures.  
 
Primary endpoint: successful instrument insertion with the Epione device  
Secondary objectives and 
endpoints / 
Objectifs 
et 
critères 
d’évaluation secondaires 
Secondary objectives:  
• 
Evaluate the safety of the Epione robotic assistance for bone percutaneous 
procedures 
• 
Evaluate the accuracy of the Epione robotic assistance for bone percutaneous 
procedures 
Secondary criteria:  

Investigation Number: EPIBONE 
ClinicalTrials.gov ID: 
CIV-ID: 2024-A00468-39 
 
Doc No: CA-BO-SYN-0053 
Revision: B 
Document title: EPIBONE Clinical Investigation Synopsis 
 
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 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 4 of 6 
• 
Adverse event(s) (AE): all AEs (serious and non-serious, related and not-related 
to the device or the procedure(s))  
• 
Lateral and angular deviations:  
o 
distance (mm) between the tip of the inserted instrument in its final 
position and its orthogonal projection on the first planned trajectory. 
o 
and angle (°) between the tip of the inserted instrument in its final 
position and the first planned trajectory. (the special case of using a 
rod through the introducer is described in the protocol) 
Eligibility criteria / 
Critères d’éligibilité 
Inclusion criteria 
• 
Patient ≥18 years, 
• 
Patient approved for CT-guided percutaneous bone procedure under general 
anaesthesia at a multidisciplinary consultation meeting,  
• 
Patient who has signed an informed consent form, 
• 
Patient covered by a social security system 
• 
Patient who has already been included in the EPIBONE study for one or more 
given musculoskeletal disorders and for whom a new location is targeted for a 
CT-guided procedure that can be assisted again by the EPIONE device. 
Exclusion criteria 
• 
Patient unable to undergo general anaesthesia, 
• 
Patient offered a procedure without appropriate breathing control,  
• 
Patient approved for CT-guided percutaneous procedures on head and neck, 
including skull and cervical vertebrae 
• 
Patient unable to fully understand all relevant aspects of the clinical study 
necessary for his/her decision to participate, or who could be manipulated or 
unduly influenced as a result of a compromised position, expectation of 
benefits or fear of retaliatory response 
• 
Pregnant or breast-feeding women, 
• 
Patient subject to a legal protection measure,  
• 
Patient already participating in another interventional clinical study, 
Device and comparator /  
Dispositif et comparateur 
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 device is indicated for use with rigid straight instruments such as needles and 
probes used in CT-guided interventional procedures performed by physicians trained 
for CT procedures on musculoskeletal structures.  
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). 
During the planning phase, the desired instrument placement and performance is 
defined relative to the target anatomy.  
During the guidance phase, the device enables to monitor respiratory levels and verify 
patient position prior to instrument advancement.  
During the assessment phase, the achieved instrument placement and performance 
are displayed relative to the previously defined plan through an overlay of the pre- 
and post-treatment image data. 

Investigation Number: EPIBONE 
ClinicalTrials.gov ID: 
CIV-ID: 2024-A00468-39 
 
Doc No: CA-BO-SYN-0053 
Revision: B 
Document title: EPIBONE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 5 of 6 
 
There is no comparator. 
Procedures to use the 
device /  
Procédure d’utilisation du 
dispositif 
The Epione device must be used in accordance with the instructions given in the study 
investigator brochure (CA-BO-IBR-0068). The device is a medical device reusable, non-
sterile intended to be mobile. The 3 instruments of the system (guide to introduce, 
patient reference and navigation probe) are reusable and must be cleaned and 
sterilized after each use. The user of the device is a Doctor specialized and trained in 
CT-guided interventional procedures. 
 
Procedures that can be carried out using the instrument inserted into the human body 
with Epione's assistance include thermal ablations, biopsies and bone consolidation 
procedures (osteoplasties and/or osteosyntheses), either alone or in combination. 
Study flowchart / 
Organigramme de l’étude 
  
 
The interventional radiologist will explain to the patient the planned procedure(s) and 
will present the response plan and its different steps during a pre-intervention 
consultation. The investigator:  
- will present the study and the device to the patient (oral and written information),  
-will review the inclusion and non-inclusion criteria of the study, and assess the 
patient's eligibility for the study,  
- Will provide the information letter and informed consent form to the patient, who 
must be able to read them and have time to think about his or her potential 
participation in the study prior to consent. 
.  
 
Demographics/medical data prior the intervention will be collected the day of the 
intervention if the patient returns a signed consent form and the investigator confirms 
the eligibility criteria. No data will be collected while prior intervention consultation, 
before signature of the written consentment.  
Sample size /  
Taille de l’échantillon 
The size of the sample of at least 67 insertions was calculated to assess the non-
inferiority of the successful insertion rate of the introducer (with the help of EPIONE), 
using a reference proportion of 96% and with a non-inferiority threshold of 0.08 under 
the assumption of 97% of feasibility for the study. 
In line with centers practice, that is to say an average of 2 insertions per patient 
(different locations of possible musculoskeletal disorders, different possible treatments 
during the same procedure ), it is planned to include a minimum of 34 patients  in this 
study. 
Randomisation 
and 
blinding /  
Randomisation et aveugle 
Not applicable. 

Investigation Number: EPIBONE 
ClinicalTrials.gov ID: 
CIV-ID: 2024-A00468-39 
 
Doc No: CA-BO-SYN-0053 
Revision: B 
Document title: EPIBONE Clinical Investigation Synopsis 
 
CATM015-A 
 Quantum Surgical – Proprietary & Confidential – Printed copies are uncontrolled unless otherwise identified  
Page 6 of 6 
Statistical 
analysis 
methods /  
Méthode 
d’analyses 
statistiques 
The statistical analysis will be performed at risk 0.05 and a power of 80%. 
The outcome of the primary endpoint will be assessed by a non-inferiority test 
compared to the results of the preclinical study. 
The primary endpoint analysis will be performed on the mITT population (modified 
Intention to Treat population). The security analysis will be carried out on the security 
population. 
A statistical analysis plan will be drafted and validated before the database is locked.  
Quantitative variables will be described using frequencies of missing and non-missing 
data, means, standard deviations, medians, quartiles, minimums and maximums. 
Qualitative variables will be described using the frequency of non-missing andof 
shortages, frequency and percentage by modality 
Study duration per patient 
/  
Durée 
de 
l’étude 
par 
patient 
The average duration of a patient's participation in the study is 1 month. The patient’s 
participation will be of a minimum of 3 weeks or a maximum of 8 weeks.  
Study schedule /  
Agenda de l’étude 
Inclusion start time: Beginning of Q3 2024 
Inclusion period: 6 months 
End of study visit of the last patient: end of Q1 2025/ Beginning of Q2 2025.