Trials / Completed
CompletedNCT05160571
A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 279 (actual)
- Sponsor
- Intuitive Surgical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ion Endoluminal System | Ion Endoluminal Procedure for pulmonary nodule |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2021-12-16
- Last updated
- 2023-03-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05160571. Inclusion in this directory is not an endorsement.