Trials / Completed
CompletedNCT03338049
All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules
Multicenter, Prospective Trial of ElectromagnetIc Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Veran Medical Technologies · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.
Detailed description
The objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (CT) utilizing (1) Electromagnetic navigation (EMN) bronchoscopy, and/or (2) EMN-transthoracic needle aspiration (TTNA). Overall diagnostic yield will be evaluated to assess the combination of these approaches.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Veran System | Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration |
Timeline
- Start date
- 2018-02-14
- Primary completion
- 2019-10-29
- Completion
- 2019-12-01
- First posted
- 2017-11-09
- Last updated
- 2020-05-19
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03338049. Inclusion in this directory is not an endorsement.