Epione® Post-Market Clinical Follow-up Study (SaFE)

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

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

Study Overview

• Status: Completed
• Conditions: Cancer Abdomen
• Intervention / Treatment: Device: EPIONE® CT-Guided Percutaneous procedures

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94000
    • Gustave Roussy Institut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention with the EPIONE® device; Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device	Device: EPIONE® CT-Guided Percutaneous procedures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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)	Visit 2 - D0 The day of the intervention
Technical Success	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)	Visit 2 - D0 The day of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle Placement Accuracy	accuracy of the needle placement: deviation between the planned and actual needle position once inserted	Visit 2 - D0 The day of the intervention
Number and Nature of Needle Adjustments to Reach the Target	Detail of the number/nature of adjustments performed after the initial insertion of the needle	Visit 2 - D0 The day of the intervention
Post-intervention Ablation Success	Minimal Ablation Margin(s) measure(s) if applicable (mm)	Until Visit 4 - Routine FU visit at 10 months
Local Tumor Recurrence	Evaluation of the local tumor progression following the ablation (if applicable)	Until Visit 4 - Routine FU visit at 10 months
Operator Satisfaction	5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied	Visit 2 - D0 The day of the intervention
Adverse Events Related to Device or Procedure	Safety of the device	Until Visit 4 - Routine FU visit at 10 months
Device Dysfunction	Evaluation of the device dysfunction	Visit 2 - D0 The day of the intervention

Collaborators and Investigators

• Sponsor: Quantum Surgical
• Investigators: Principal Investigator: Baptiste BONNET, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): April 27, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Biopsy; Ablation; Robotics; Percutaneous; Kidney; Liver; CT-guided; Abscess Drainage; Fiducial Placement; Abdomen
• Other Study ID Numbers: QS-NIS-G-H-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No