N/A
N=25
EPIONE Guided Lung Evaluation
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05651867 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Jul 2025
Primary outcome: Primary: Feasibility of the Device — 26 Number of targets reached
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EPIONE device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quantum Surgical
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Device |
26 | — |
| SECONDARY Needle Placement Accuracy |
1.2 | — |
| SECONDARY Number of Needle Adjustments |
0.8 | — |
| SECONDARY Post-intervention Ablation Success |
20 | — |
| SECONDARY Long-term Efficacy of Ablation |
18 | — |
| SECONDARY Adverse Event |
5 | — |
| SECONDARY Grade of Needle Adjustment |
7; 17; 1; 6 | — |
Summary
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Patient unable to undergo general anesthesia,
- Pregnant or nursing female, confirmed before the intervention
- Patient already participating in another clinical study
Data sourced from ClinicalTrials.gov (NCT05651867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.