Clinical trial · Observational
A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
NCT05160571CI-TRIAL-00064423completedClinicalTrials.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)
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the 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
- Subjects with Ion Endoluminal sampling of pulmonary nodule
- description
- Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System
- interventionNames
- Device: Ion Endoluminal System
Primary outcomes (4)
- measure
- Diagnostic yield
- timeFrame
- Intra-operative through the one year follow up period
- description
- Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)
- measure
- Sensitivity for malignancy
- timeFrame
- Intra-operative through the one year follow up period
- description
- Sensitivity for malignancy of the sample obtained
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject was 18 years or older at the time of the procedure * Biopsy procedure attempted/performed using the Ion Endoluminal System Exclusion Criteria: * Biopsy procedure was not attempted with the Ion Endoluminal System * Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval
References
Publications (0)
Data not yet available
No reference posted for this study.