European registry tracking use of the Ion system for lung nodule biopsy and localization
A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
This will collect real-world data to see how well the Ion endoluminal system works for adults having elective lung nodule biopsies or localization procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intuitive Surgical Industry-sponsored |
| Locations | 5 sites (Le Plessis-Robinson and 4 other locations) |
| Trial ID | NCT06923774 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older who are planned to undergo an elective lung lesion biopsy and/or localization using the Ion endoluminal system and can give informed consent are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, legally incapacitated or in vulnerable populations, participating in conflicting interventional trials, or unwilling to comply with follow-up are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could provide evidence that the Ion system enables accurate and safe bronchoscopic biopsy and localization of lung nodules, helping improve diagnostic confidence and care planning.
How similar studies have performed: Robotic and advanced bronchoscopic platforms similar to the Ion system have shown promising feasibility and diagnostic yield in prior studies, though large real-world registries remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Le Plessis-Robinson and 4 other locations
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France (Recruiting)
- Helios Klinikum Emil von Behring — Berlin, Germany (Not_yet_recruiting)
- Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- Wythenshawe Hospital, Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jana Meschede
- Email: IonEURegistry@intusurg.com
- Phone: +41 21 821 2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.