NCT05651867

EPIONE Guided Lung Evaluation

Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Quantum Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

Detailed description

The objectives are: * to evaluate the technical success of the device * to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence) * to evaluate the safety of the device 25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	EPIONE 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.

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-08-25
• Completion: 2024-09-10
• First posted: 2022-12-15
• Last updated: 2025-07-15
• Results posted: 2025-07-15

Locations

1 site across 1 country: France