Clinical trial · Observational
Real World Registry for Use of the Ion Endoluminal System
A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
NCT06004440CI-TRIAL-00109415active not recruitingClinicalTrials.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 primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
Conditions
Conditions (9)
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 |
| Lung Diseases | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Respiratory Tract Diseases | — | UNRESOLVED | — |
| Respiratory Tract Neoplasms | Respiratory System Neoplasm | ALIAS | 0.90 |
| Thoracic Neoplasms | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ion Endoluminal System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System
- description
- Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.
- interventionNames
- Device: Ion Endoluminal System
Primary outcomes (1)
- measure
- Primary Endpoint to Assess Diagnostic Yield
- timeFrame
- Intra-procedure through the 24 month follow up period
- description
- 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
- Secondary Endpoint to Assess Pneumothorax
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is 18 years or older at the time of the index procedure. * Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System. * Subject able to understand and adhere to study requirements and provide informed consent. Exclusion Criteria: * Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord. * Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study. * Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices. * Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.
References
Publications (0)
Data not yet available
No reference posted for this study.