Epione® Post-Market Clinical Follow-up Study

Active, not recruiting

• Conditions: Cancer Abdomen
• Interventions: Device: EPIONE® CT-Guided Percutaneous procedures

• Registration Number: NCT05529979
• Lead Sponsor: Quantum Surgical

Brief 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.

Study Timeline

• Study Start: 2022-04-21
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-07
• Primary Completion: 2023-02-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention with the EPIONE® device	EPIONE® CT-Guided Percutaneous procedures	Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device

Primary Outcome Measures

Name	Time	Method
Technical Success	through study completion up to 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events related to device or procedure	through study completion up to 36 months	Safety of the device
Device dysfunction	through study completion up to 36 months	Evaluation of the device dysfunction
Needle placement accuracy	through study completion up to 36 months	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	through study completion up to 36 months	Detail of the number/nature of adjustments performed after the initial insertion of the needle
Post-intervention ablation success	through study completion up to 36 months	Minimal Ablation Margin(s) measure(s) if applicable (mm)
Operator satisfaction	through study completion up to 36 months	5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied
Local tumor recurrence	through study completion up to 36 months	Evaluation of the local tumor progression following the ablation (if applicable)

Trial Locations

Locations (1)

Gustave Roussy Institut; 🇫🇷 Villejuif, France