Lung CancerEGLENCT05651867
EPIONE Guided Lung Evaluation
A study testing EPIONE device in people with Lung Cancer, run by Quantum Surgical at 1 site in France.
Trial summary
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EPIONE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2022to 10 Sep 2024
- 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 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.
Who cannot join
- Patient unable to undergo general anesthesia,
- Pregnant or nursing female, confirmed before the intervention
- Patient already participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- EPIONE device
- Keywords
- percutaneous, CT-guided, Ablation, Biopsy, Abcess Drainage, Fiducial placement, Lung, Robotics
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIONE deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device Receives: Device: EPIONE device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Device
Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.
Measured: an average of 7 months
Secondary outcomes (6)
Needle Placement Accuracy
accuracy of the needle placement: deviation between the planned and actual needle position once inserted.
Measured: an average of 7 months
Number of Needle Adjustments
Detail of the number/nature of adjustments performed after the initial insertion of the needle.
Measured: an average of 7 months
Post-intervention Ablation Success
If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success
Measured: an average of 1 year
Long-term Efficacy of Ablation
If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed.
We count here the patient treated for which the lesion ablated did not show recurrence after 12 months.
Measured: through study completion, an average of 1 year
Adverse Event
number of patients experiencing a serious adverse event
Measured: through study completion, an average of 21 months
Grade of Needle Adjustment
Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body)
Measured: an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start28 Nov 2022
- Primary completion25 Aug 2023
- Study completion10 Sep 2024
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.
- Other trials for Lung CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baptiste BONNET, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651867
- Sponsor's protocol ID
- QS-IS-G-H-2201
- Acronym
- EGLE
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2022
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs
- ClinicalTrials.gov ID
- NCT05651867
- Acronym / sponsor ID
- EGLE / QS-IS-G-H-2201
- Conditions
- Lung Cancer
- Keywords
- percutaneous, CT-guided, Ablation, Biopsy, Abcess Drainage, Fiducial placement, Lung, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Quantum SurgicalIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Posted 15 Jul 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 percutaneous procedures in the lung.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: EPIONE devicePatients treated by percutaneous CT-guided procedures in the lung 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 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.
Key exclusion criteria (3 listed)
- Patient unable to undergo general anesthesia,
- Pregnant or nursing female, confirmed before the intervention
- Patient already participating in another clinical study
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 |
|---|---|---|
| EPIONE deviceThe 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. | Device | Interventional arm |
Primary outcome
Feasibility of the Device
Time frame: an average of 7 months
Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.
6 secondary outcomes
Needle Placement Accuracy
Time frame: an average of 7 months
Number of Needle Adjustments
Time frame: an average of 7 months
Post-intervention Ablation Success
Time frame: an average of 1 year
Long-term Efficacy of Ablation
Time frame: through study completion, an average of 1 year
Adverse Event
Time frame: through study completion, an average of 21 months
Grade of Needle Adjustment
Time frame: an average of 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIONE device in people with Lung Cancer, run by Quantum Surgical at 1 site 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 3 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 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 15 Jul 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?
Feasibility of the Device (time frame: an average of 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.