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Trial Title:
Epione® Post-Market Clinical Follow-up Study
NCT ID:
NCT05529979
Condition:
Cancer Abdomen
Conditions: Keywords:
Percutaneous
CT-guided
Ablation
Biopsy
Abscess Drainage
Fiducial Placement
Abdomen
Liver
Kidney
Robotics
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
EPIONE® CT-Guided Percutaneous procedures
Description:
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.
Arm group label:
Intervention with the EPIONE® device
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
Detailed description:
The objective of this PMCF study is to compile data on the routine use of the EPIONE®
device in subjects undergoing CT-guided percutaneous procedures in the abdomen.
The objectives are:
1. to evaluate the technical success of the device
2. to evaluate performance parameters (accuracy measures, adjustements,
post-intervention ablation success, local tumor recurrence, operator satisfaction)
and the safety of the device
55 patients are planned in this post-market study.
Criteria for eligibility:
Study pop:
Patients treated/operated in routine practice, in accordance with the device's intended
use, without any additional nor burdensome procedure.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy Institut
Address:
City:
Villejuif
Zip:
94000
Country:
France
Start date:
April 21, 2022
Completion date:
November 2023
Lead sponsor:
Agency:
Quantum Surgical
Agency class:
Industry
Source:
Quantum Surgical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05529979
