Lung Cancer, Pulmonary Nodule
Conditions
Brief summary
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.
Detailed description
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).
Interventions
DEVICEIon Endoluminal System
Ion Endoluminal 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 was 18 years or older at the time of the procedure * Biopsy procedure attempted/performed using the Ion Endoluminal System
Exclusion criteria
* Biopsy procedure was not attempted with the Ion Endoluminal System * Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Intra-operative through the one year follow up period | Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied) |
| Sensitivity for malignancy | Intra-operative through the one year follow up period | Sensitivity for malignancy of the sample obtained |
| Pneumothorax | Intra-operative | Incidence of all pneumothoraces related to the Ion procedure |
| Bleeding | Intra-operative | Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Intra-operative through 30 days | All adverse events related to the Ion procedure |
| Conversion to alternate approach or termination of procedure | Intra-operative | Rate of procedures converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology \[ex., electromagnetic navigational bronchoscopy\] or a different procedure \[ex., CT-guided transthoracic needle aspiration\]) after the Ion catheter has entered the endotracheal tube. Termination is defined as prematurely ending the procedure after the Ion catheter has entered the endotracheal tube but before the biopsy sample has been obtained. |
Countries
United States
Outcome results
None listed