A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Intuitive Surgical
- Enrollment
- 279
- Locations
- 1
- Primary Endpoint
- Sensitivity for malignancy
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sensitivity for malignancy
Time Frame: Intra-operative through the one year follow up period
Sensitivity for malignancy of the sample obtained
Pneumothorax
Time Frame: Intra-operative
Incidence of all pneumothoraces related to the Ion procedure
Diagnostic yield
Time Frame: 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)
Bleeding
Time Frame: 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 Outcomes
- Adverse events(Intra-operative through 30 days)
- Conversion to alternate approach or termination of procedure(Intra-operative)