Epione® Post-Market Clinical Follow-up Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-28

Study Completion Date

2024-04-27

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cancer Abdomen

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention with the EPIONE® device

Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device

EPIONE® CT-Guided Percutaneous procedures

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.