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Clinical Trial 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


Clinical Trial 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 Design


NCT number NCT05529979
Study type Observational
Source Quantum Surgical
Contact
Status Active, not recruiting
Phase
Start date April 21, 2022
Completion date November 2023