Clinical trial · Observational
European Real-World Registry for Use of the Ion Endoluminal System
A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
NCT06923774CI-TRIAL-00120374recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ion endoluminal system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation Group
- description
- Subjects with biopsy and/or localization of lung nodule(s)
- interventionNames
- Device: Ion endoluminal system
Primary outcomes (1)
- measure
- Diagnostic Yield
- timeFrame
- Intra-procedure through 24 month post-procedure
- description
- 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.
Secondary outcomes (2)
- measure
- Pneumothorax
- timeFrame
- Intra-procedure through 30 days post-procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.