European Real-World Registry for Use of the Ion Endoluminal System

Last updated: March 23, 2026
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Lung Disease

Lung Cancer

Treatment

Ion endoluminal system

Clinical Study ID

NCT06923774
1147383C
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to collect collect real-world data for the Ion endoluminal system.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is aged 18 years or older at time of consent.

  • Patient is planned to undergo a lung lesion biopsy(s) and/or localizationprocedure(s) utilizing the Ion endoluminal system.

  • Patient is willing and able to give written informed consent for clinical studyparticipation.

Exclusion

Exclusion Criteria:

  • Patient is participating in an interventional research study or research study withinvestigational agents with an unknown safety profile that would interfere withparticipation in this study or study results.

  • Female patient that is pregnant or breast feeding as determined by standard sitepractices.

  • Patient is legally incapacitated or in a legal/court ordered institution or is partof a known vulnerable population, including but not limited to dependency on thesponsor, hospital or study doctor.

  • Patient is not willing to comply with post-procedure study participationrequirements.

  • Investigator, in their professional opinion, has decided that it is in the patient'sbest interest to not participate in the clinical study.

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Ion endoluminal system
Phase:
Study Start date:
September 09, 2025
Estimated Completion Date:
October 31, 2029

Study Description

This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.

Connect with a study center

  • Hôpital Marie Lannelongue

    Le Plessis-Robinson, 92350
    France

    Active - Recruiting

  • Hôpital Marie Lannelongue

    Le Plessis-Robinson 3002650, 92350
    France

    Site Not Available

  • Helios Klinikum Emil von Behring

    Berlin, 14165
    Germany

    Site Not Available

  • Helios Klinikum Emil von Behring

    Berlin 2950159, 14165
    Germany

    Site Not Available

  • Universitätsspital Zürich

    Zurich, 8091
    Switzerland

    Active - Recruiting

  • Universitätsspital Zürich

    Zurich 2657896, 8091
    Switzerland

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust

    London 2643743, NW1 2BU
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital, Manchester University NHS Foundation Trust

    Manchester, M23 9LT
    United Kingdom

    Active - Recruiting

  • Wythenshawe Hospital, Manchester University NHS Foundation Trust

    Manchester 2643123, M23 9LT
    United Kingdom

    Site Not Available

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