Bone MetastasesEPIBONENCT06376682

EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy

A study testing CT-guided bone percutaneous procedure in people with Bone Metastases and Fractures, Bone, run by Quantum Surgical at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bone Metastases, Fractures, Bone, Bone Tumor
What is being tested?: CT-guided bone percutaneous procedure
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 3 sitesFrance
Study dates: 16 Sep 2024to 6 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient ≥18 years,
Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
Patient who has signed an informed consent form,
Patient covered by a social security system,

Who cannot join

Patient with contraindication to general anaesthesia,
Patient undergoing a procedure without appropriate breathing control,
Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
Pregnant or breast-feeding women,
Patient under legal protection (tutorship, guardianship, …),
Patient already participating in another interventional clinical study.

Trial locations and contacts

3 sites in 1 country.

France3 sites

Hospices Civils de Lyon
Lyon, 69000
Institut Paoli-Calmettes
Marseille, 13000
Institut Gustave Roussy
Villejuif, 94800

Other trials in France

About this study

Official title: Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy

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

Read the detailed description

The objectives are:

To evaluate the feasibility of the Epione robotic assistance for bone percutaneous procedures.
To evaluate the safety and the accuracy of the Epione robotic assistance for bone percutaneous procedures.

At least 34 patients (representing at least 67 insertions, as one patient may undergo one or more insertions during the procedure) have been planned for the study. They will be treated by the clinician using the Epione device during a CT-guided percutaneous procedure in musculoskeletal (MSK) structures.

Conditions: Bone Metastases, Fractures, Bone, Bone Tumor
Being tested: CT-guided bone percutaneous procedure
Keywords: Robotic, Robotic guidance, Percutaneous, CT-guided, Bone consolidation, Thermal ablation
Medical subject headings: Fractures, Bone, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-guided bone percutaneous procedureProcedure or surgery
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 (thermal ablation, bone consolidation, biopsy procedures).

Study groups in NCT06376682
Study group	Role	What they receive
Interventional arm	Experimental	Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device Receives: Procedure: CT-guided bone percutaneous procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful Introducer Insertion With the EPIONE Device.
To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique
Measured: Day of the procedure

Secondary outcomes (3)

Adverse Event(s) (AE)
To evaluate the safety of the EPIONE robotic assistance for bone percutaneous procedures: all AEs (serious and non-serious, related and not-related to the device or the procedure(s))
Measured: Up to 1 month
Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures
To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Lateral deviation: distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory
Measured: Day of the procedure
Angular Deviation (°)
To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Angular deviation (°): 3D angle between the inserted introducer in its final position and the first planned trajectory.
Measured: Day of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 20246 Jan 2025

First posted19 Apr 2024
Study start16 Sep 2024
Primary completion29 Nov 2024
Study completion6 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bone MetastasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06376682
Sponsor's protocol ID: CA-BO-CIP-0060
Acronym: EPIBONE
Status last verified: Sep 2025
First submitted: 10 Apr 2024
Last updated: 22 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bonnet B, Stacoffe N, Dassa M, Tselikas L, Beunon P, Tutton S, Pialat JB, Milot L, Thiery L, Mastier C, Daidj N, Boulade W, de Baere T, Deschamps F, Piana G. Robotic-Assisted Computed Tomography-Guided Percutaneous Bone Procedures: A Prospective Multicenter Pilot Study. Cardiovasc Intervent Radiol. 2026 Jul 29. doi: 10.1007/s00270-026-04545-w. Online ahead of print.
PubMed 42527616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy
ClinicalTrials.gov ID: NCT06376682
Acronym / sponsor ID: EPIBONE / CA-BO-CIP-0060
Conditions: Bone Metastases, Fractures, Bone, Bone Tumor
Keywords: Robotic, Robotic guidance, Percutaneous, CT-guided, Bone consolidation, Thermal ablation
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Quantum SurgicalIndustry (pharma, biotech, devices)
Collaborators: ICUREsearch
Study start: 16 Sep 2024 (actual)
Primary completion: 29 Nov 2024 (actual)
Study completion: 6 Jan 2025 (actual)
First posted: 19 Apr 2024 (actual)
Results: Posted 22 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The objectives are:

To evaluate the feasibility of the Epione robotic assistance for bone percutaneous procedures.
To evaluate the safety and the accuracy of the Epione robotic assistance for bone percutaneous procedures.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.

Arm	Type	Receives
Interventional arm	Experimental	Procedure: CT-guided bone percutaneous procedurePatients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient ≥18 years,
Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
Patient who has signed an informed consent form,
Patient covered by a social security system,

Key exclusion criteria (7 listed)

Patient with contraindication to general anaesthesia,
Patient undergoing a procedure without appropriate breathing control,
Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
Pregnant or breast-feeding women,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-guided bone percutaneous procedureThe 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 (thermal ablation, bone consolidation, biopsy procedures).	Procedure or surgery	Interventional arm

Primary outcome

Successful Introducer Insertion With the EPIONE Device.
Time frame: Day of the procedure
To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique

3 secondary outcomes

Adverse Event(s) (AE)
Time frame: Up to 1 month
Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures
Time frame: Day of the procedure
Angular Deviation (°)
Time frame: Day of the procedure

Results and safety

Results posted to the registry on 22 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interventional Arm	34	32

Primary outcome: Successful Introducer Insertion With the EPIONE Device.

Time frame: Day of the procedure. Number. Unit: Successful insertion

Measure	Interventional Arm n = 34
Value	89

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interventional Arm	4 of 34 (11.8%)	3 of 34 (8.8%)	2 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42527616Bonnet B, Stacoffe N, Dassa M, Tselikas L, Beunon P, Tutton S, Pialat JB, Milot L, Thiery L, Mastier C, Daidj N, Boulade W, de Baere T, Deschamps F, Piana G. Robotic-Assisted Computed Tomography-Guided Percutaneous Bone Procedures: A Prospective Multicenter Pilot Study. Cardiovasc Intervent Radiol. 2026 Jul 29. doi: 10.1007/s00270-026-04545-w. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Baptiste BONNET principal investigator

Gustave Roussy Cancer Institute

Nicolas STACOFFE principal investigator

Hospices Civils de Lyon

Gilles PIANA principal investigator

Paoli-Calmettes Institute

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CT-guided bone percutaneous procedure in people with Bone Metastases and Fractures, Bone, run by Quantum Surgical at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Introducer Insertion With the EPIONE Device. (time frame: Day of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376682, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.