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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
| Siemens Corporation, Corporate Technology | INDUSTRY |
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Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Nodule | Pulmonary nodule is suitable for elective bronchoscopy with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ion Endoluminal System | Diagnostic Test | Robotic bronchoscopy with c-arm imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tool in Lesion | Ability to visualize on 3D imaging the pre-planned target location characterized when displayed distance of catheter tip to nearest edge of the virtual target is ≤ 2cm and is oriented towards the lesion in 3 axes. | At the time of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complications | Overall incidence of procedure-related complications recorded as adverse events. | 6 months |
| Duration-related outcomes | Reporting of times related to procedure times including procedure time, navigation time, time to 3D confirmation, time to tissue acquisitions, anesthesia time, and fluoroscopy time and dose. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from pulmonary, medical oncology or thoracic surgery departments at the Mayo Clinic Rochester.
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| Name | Affiliation | Role |
|---|---|---|
| Janani Reisenauer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35509435 | Derived | Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun. |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| At the time of the procedure |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |