A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin |
Device: Ion Endoluminal System and Cios Spin
Integrated version of the Ion Endoluminal System and Cios Spin
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 2 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
- Principal Investigator: Roberto Casal, MD, MD Anderson
- Principal Investigator: Bryan Husta, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISI-ION-002