N/A
N=55
Epione® Post-Market Clinical Follow-up Study
Cancer Abdomen
Bottom Line
View on ClinicalTrials.gov: NCT05529979 ↗Enrolled (actual)
55
Serious AEs
5.6%
Results posted
Jan 2026
Primary outcome: Primary: Technical Success — 50 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- EPIONE® CT-Guided Percutaneous procedures (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quantum Surgical
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success |
56 | — |
| PRIMARY Technical Success |
56 | — |
| SECONDARY Needle Placement Accuracy |
— | — |
| SECONDARY Number and Nature of Needle Adjustments to Reach the Target |
— | — |
| SECONDARY Post-intervention Ablation Success |
— | — |
| SECONDARY Local Tumor Recurrence |
— | — |
| SECONDARY Operator Satisfaction |
— | — |
| SECONDARY Adverse Events Related to Device or Procedure |
— | — |
| SECONDARY Device Dysfunction |
— | — |
Summary
Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen
Eligibility Criteria
Inclusion Criteria
- Patient >18 years old,
- Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- Patient with a confirmed non-opposition.
Exclusion Criteria
- Patient unable to undergo general anesthesia,
- Pregnant or breast-feeding females
Data sourced from ClinicalTrials.gov (NCT05529979). 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.