Lung Cancer
Conditions
Brief summary
The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.
Detailed description
This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.
Interventions
DEVICEIon Endoluminal System
Ion Endoluminal dye marking procedure for pulmonary nodule
Sponsors
Intuitive Surgical
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
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. * Dye marking attempted/performed using the Ion Endoluminal Platform
Exclusion criteria
* Resection not performed following dye marking procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful dye injection | Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure | The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample |
| Pneumothorax | Intra-procedure | Incidence of all pneumothoraces related to the Ion procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intra-operative | Time from start of resection procedure to end of resection procedure (skin-to-skin time) |
| Adverse events | Intra-procedure until the start of the resection procedure | All adverse events related to the Ion procedure |
| Conversion to alternate approach or termination of procedure due to localization issues | Intra-operative | Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology \[ex., open resection\] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed. |
| Type of resection planned and performed | Intra-operative | The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started. |
| Procedure time | Intra-procedure | Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube \[ETT\]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT). |
Countries
United States
Outcome results
None listed