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Completed

NCT Number: NCT05651867

EPIONE Guided Lung Evaluation

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

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy Institut

Villejuif, 94000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPIONE device

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.

Primary outcomes

  1. Feasibility of the Device

    Time frame: an average of 7 months

    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.

Secondary outcomes

  1. Needle Placement Accuracy

    Time frame: an average of 7 months

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

  2. Number of Needle Adjustments

    Time frame: an average of 7 months

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

  3. Post-intervention Ablation Success

    Time frame: an average of 1 year

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

  4. Long-term Efficacy of Ablation

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

    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.

  5. Adverse Event

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

    number of patients experiencing a serious adverse event

  6. Grade of Needle Adjustment

    Time frame: an average of 7 months

    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)

Sponsors and collaborators

Lead sponsor

Quantum Surgical

Industry

Registry information

Official study title

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

Acronym: EGLE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 15, 2022
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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