EPIONE Guided Lung Evaluation (EGLE)

Quantum Surgical

Status: Completed

Conditions: Lung Cancer

Treatments: Device: EPIONE device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05651867

QS-IS-G-H-2201

Details and patient eligibility

About

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

Full 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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Interventional arm

Experimental group

Description:

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

Treatment:

Device: EPIONE device