NCT02582944

Electromagnetic Navigation for Peripheral Pulmonary Lesions

Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.

Conditions

• Peripheral Lung Lesions

Interventions

Type	Name	Description
DEVICE	Olympus BF-180 bronchoscope (standard adult)	-Standard of care
DEVICE	Veran Spinview Thoracic Navigation System	-Electromagnetic navigation
DEVICE	Olympus UM-S20-17S	-Endobronchial ultrasound mini-probe
PROCEDURE	Biopsy

Timeline

• Start date: 2015-03-25
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2015-10-21
• Last updated: 2017-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study