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Clinical Trials/NCT05651867
NCT05651867CompletedNot Applicable

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

Quantum Surgical2 sites in 1 country25 target enrollmentStarted: November 28, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Feasibility of the Device
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Needle Placement Accuracy(an average of 7 months)
  • Number of Needle Adjustments(an average of 7 months)
  • Post-intervention Ablation Success(an average of 1 year)
  • Long-term Efficacy of Ablation(through study completion, an average of 1 year)
  • Adverse Event(through study completion, an average of 21 months)
  • Grade of Needle Adjustment(an average of 7 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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