Epione® Post-Market Clinical Follow-up… | Clinical Trial

Key information

Conditions

Cancer Abdomen

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gustave Roussy Institut

Villejuif, 94000, France

About this study

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:

to evaluate the technical success of the device
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPIONE® CT-Guided Percutaneous procedures

Device

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.

Primary outcomes

Technical Success

Time frame: Visit 2 - D0 The day of the intervention

Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by patient)
Technical Success

Time frame: Visit 2 - D0 The day of the intervention

Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by lesion)

Secondary outcomes

Needle Placement Accuracy

Time frame: Visit 2 - D0 The day of the intervention

accuracy of the needle placement: deviation between the planned and actual needle position once inserted
Number and Nature of Needle Adjustments to Reach the Target

Time frame: Visit 2 - D0 The day of the intervention

Detail of the number/nature of adjustments performed after the initial insertion of the needle
Post-intervention Ablation Success

Time frame: Until Visit 4 - Routine FU visit at 10 months

Minimal Ablation Margin(s) measure(s) if applicable (mm)
Local Tumor Recurrence

Time frame: Until Visit 4 - Routine FU visit at 10 months

Evaluation of the local tumor progression following the ablation (if applicable)
Operator Satisfaction

Time frame: Visit 2 - D0 The day of the intervention

5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied
Adverse Events Related to Device or Procedure

Time frame: Until Visit 4 - Routine FU visit at 10 months

Safety of the device
Device Dysfunction

Time frame: Visit 2 - D0 The day of the intervention

Evaluation of the device dysfunction

Sponsors and collaborators

Lead sponsor

Quantum Surgical

Industry

Registry information

Official study title

Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

Acronym: SaFE

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Sep 7, 2022
Registry last updated: Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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