European registry tracking use of the Ion system for lung nodule biopsy and localization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational, multi-center, single-arm post-market registry collecting real-world procedural details and short- and long-term clinical outcomes after use of the CE-marked Ion endoluminal system for elective lung nodule biopsy or localization. About 1,200 adults who undergo an attempted or performed biopsy and/or localization with the device will be enrolled across participating European centers. The device will be used according to its approved indications and local standard-of-care, and data will capture procedural characteristics, complications, and diagnostic outcomes. No experimental interventions or randomized comparisons are planned.

Why it matters

Who can join: the full rules

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 localization procedure(s) utilizing the Ion endoluminal system.
* Patient is willing and able to give written informed consent for clinical study participation.

Exclusion Criteria:

* Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
* Female patient that is pregnant or breast feeding as determined by standard site practices.
* Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.
* Patient is not willing to comply with post-procedure study participation requirements.
* Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.

Where it's running

• Hôpital Marie Lannelongue
  Le Plessis-Robinson, France Recruiting
• Helios Klinikum Emil von Behring
  Berlin, Germany Recruiting
• DGD Lungenklining Hemer
  Hemer, Germany Recruiting
• Helios Dr. Horst Schmidt Kliniken
  Wiesbaden, Germany Recruiting
• Universitätsspital Zürich
  Zurich, Switzerland Recruiting
• University College London Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Jana Meschede
• Email: IonEURegistry@intusurg.com
• Phone: +41 21 821 2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.