European Multi-Center Study to Collect Real-World Data on the Ion Endoluminal System for Lung Nodule Biopsy and Localization

What this Trial Is About

Researchers are collecting real-world data to evaluate the Ion endoluminal system, a device used for biopsies and localization of lung nodules. This observational study is conducted across multiple centers in Europe and aims to observe procedural details and both short- and long-term clinical outcomes following the use of this CE-marked device. Approximately 1,200 patients undergoing elective lung nodule biopsy or localization will be enrolled according to specific eligibility criteria. Participants will undergo lung lesion biopsy andor localization procedures using the Ion endoluminal system as part of their standard care. This is a single-arm, prospective study without randomization or control groups. The study observes the real-world use of the device after its market approval, following patients from the procedure through follow-up periods. During the study, participants will be monitored for diagnostic yield from the procedure through 24 months post-procedure. Researchers will also track safety outcomes such as pneumothorax and bleeding from the procedure through 30 days afterwards. Participants will provide informed consent and be observed according to the protocol without altering their usual treatment. The total study duration extends through 2029, with continued data collection throughout that time.

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