Clinical trial · Observational
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
NCT05562895CI-TRIAL-00097180completedClinicalTrials.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 overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ion Endoluminal System and Cios Spin | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin
- description
- Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin
- interventionNames
- Device: Ion Endoluminal System and Cios Spin
Primary outcomes (3)
- measure
- Diagnostic yield
- timeFrame
- Intra-procedure through the 13 month follow up period
- description
- Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied
- measure
- Sensitivity for malignancy
- timeFrame
- Intra-procedure through the 13 month follow up period
- description
- Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy
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 procedure. * Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging. * Pulmonary nodule ≤2 cm in largest diameter. * Subject able to understand and adhere to study requirements and provide informed consent. Exclusion Criteria: * Planned lymph node staging performed before nodule biopsy. * Nodule is a pure ground glass opacity. * Plan to biopsy multiple nodules.
References
Publications (1)
- DERIVEDHusta BC, Cheng GZ, Batra H, Reisenauer JS, Bartek WM, Kalchiem-Dekel O, Zouk A, Patel N, Chawla M, Eapen GA, Jimenez CA, Lee RP, Bott MJ, Oh S, Casal RF. Shape-sensing robotic-assisted bronchoscopy with integrated mobile cone-beam CT for small nodules: results from the prospective multicentre CONFIRM study. Thorax. 2026 Feb 16;81(3):267-275. doi: 10.1136/thorax-2025-223272. PMID 41698810