Lung Cancer
Conditions
Brief summary
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.
Detailed description
This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.
Interventions
DEVICEIon Endoluminal System and Cios Spin
Integrated version of the Ion Endoluminal System and Cios Spin
Sponsors
Intuitive Surgical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Intra-procedure through the 13 month follow up period | Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied |
| Sensitivity for malignancy | Intra-procedure through the 13 month follow up period | Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy |
| Rate of tool in nodule | Intra-procedure | Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total radiation dose | Intra-procedure | Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm\^2) |
| Time to achieve tool in nodule | Intra-procedure | Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging |
Countries
United States
Outcome results
None listed