Clinical Trials in France / NCT06923774
Recruiting
Observational
European Real-World Registry for Use of the Ion Endoluminal System
NCT06923774 · tracked via the Priya Life Science France tracker
Condition(s) studied
Pulmonary NoduleLung Cancer
Investigational drug(s) / intervention(s)
Ion endoluminal system
Ion endoluminal system: Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care
Study summary
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
Eligibility
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.
Primary outcome measure(s)
- Diagnostic Yield — Intra-procedure through 24 month post-procedure
Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Brest, Hôpital de La Cavale Blanche | Brest | France | Not Yet Recruiting |
| Hôpital Marie Lannelongue | Le Plessis-Robinson | France | Recruiting |
| CHU de Rouen | Rouen | France | Not Yet 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 |
| Wythenshawe Hospital, Manchester University NHS Foundation Trust | Manchester | United Kingdom | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06923774 on ClinicalTrials.gov ↗ ← All trials in France