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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ion Endoluminal System and Cios Spin | Device | Integrated version of the Ion Endoluminal System and Cios Spin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied | Intra-procedure through the 13 month follow up period |
| Sensitivity for malignancy | Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy | Intra-procedure through the 13 month follow up period |
| Rate of tool in nodule | 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) | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total radiation dose | Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm^2) | Intra-procedure |
| Time to achieve tool in nodule |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 18 years or older
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Casal, MD | MD Anderson | Principal Investigator |
| Bryan Husta, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California San Diego, Hillcrest Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41698810 | Derived | Husta 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging
| Intra-procedure |
| San Diego |
| California |
| 92103 |
| United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| South Austin Hospital | Austin | Texas | 78704 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |