Epione® Post-Market Clinical Follow-up Study

Quantum Surgical55 enrolled

Overview

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

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

Conditions

Cancer Abdomen

Interventions

EPIONE® CT-Guided Percutaneous proceduresDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Gustave Roussy Institut

Villejuif, France

Outcomes

Primary Outcomes

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)

Time frame: 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)

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

Secondary Outcomes

Needle Placement Accuracy

accuracy of the needle placement: deviation between the planned and actual needle position once inserted

Time frame: 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

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

Post-intervention Ablation Success

Minimal Ablation Margin(s) measure(s) if applicable (mm)

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

Local Tumor Recurrence

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

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

Operator Satisfaction

5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied

Data from ClinicalTrials.gov

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