EPIONE Guided Lung Evaluation

Quantum Surgical25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

EPIONE deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient ≥18 years old, * Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians, * Patient with a signed informed consent form. * Patient covered by a social security system. Exclusion Criteria: * Patient unable to undergo general anesthesia, * Pregnant or nursing female, confirmed before the intervention * Patient already participating in another clinical study

Locations (1)

Gustave Roussy Institut

Villejuif, France

Outcomes

Primary Outcomes

Feasibility of the Device

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

Time frame: an average of 7 months

Secondary Outcomes

Needle Placement Accuracy

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

Time frame: an average of 7 months

Number of Needle Adjustments

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

Time frame: an average of 7 months

Post-intervention Ablation Success

If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success

Time frame: an average of 1 year

Long-term Efficacy of Ablation

If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed. We count here the patient treated for which the lesion ablated did not show recurrence after 12 months.

Time frame: through study completion, an average of 1 year

Adverse Event

number of patients experiencing a serious adverse event

Time frame: through study completion, an average of 21 months

Grade of Needle Adjustment

Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body)

Data from ClinicalTrials.gov

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