Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Symptoms and General Pathology

Lung Neoplasms

Abscess

Patients treated by percutaneous CT-guided procedures in the lung with the 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.

EPIONE device

THIERRY DE BAERE, MD

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

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

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

Number of targets reached ; the target is considered reached when the needle is positioned accurately enough to allow the planned procedure to be performed.

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

Detail of the number/nature of adjustments performed after the initial insertion of the needle.

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

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

Quantum Surgical

Hematinics

All Drugs and Chemicals

Liver Extracts

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

EPIONE® CT-Guided Percutaneous procedures

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.

Epione® Post-Market Clinical Follow-up Study

Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

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.

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

Detail of the number/nature of adjustments performed after the initial insertion of the needle

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EPIONE Guided Lung Evaluation	NCT05651867	Lung Cancer	EPIONE device	18 Years -	Quantum Surgical
EPIONE Guided Lung Evaluation	NCT05651867	Lung Cancer	EPIONE device	18 Years -	Quantum Surgical
EPIONE Guided Lung Evaluation	NCT05651867	Lung Cancer	EPIONE device	18 Years -	Quantum Surgical
Epione® Post-Market Clinical Follow-up Study	NCT05529979	Cancer Abdomen	EPIONE® CT-Guid...	18 Years -	Quantum Surgical

Spots Global Cancer Trial Database for fiducial placement