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

Quantum Surgical

Status: Completed

Conditions: Cancer Abdomen

Treatments: Device: EPIONE® CT-Guided Percutaneous procedures

Study type: Observational

Funder types: Industry

Identifiers

NCT05529979

QS-NIS-G-H-2101

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Intervention with the EPIONE® device

Description:

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

Treatment:

Device: EPIONE® CT-Guided Percutaneous procedures