NCT03536026

Localization of Peripheral Pulmonary Lesions: A Pilot Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (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. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.

Conditions

• Peripheral Lung Lesions

Interventions

Type	Name	Description
PROCEDURE	Conventional bronchoscopy	-Standard of care
DEVICE	VIDA Pulmonary Workstation 2	-Virtual bronchoscopic navigation system
PROCEDURE	Biopsy	-Standard of care

Timeline

• Start date: 2018-04-30
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-05-24
• Last updated: 2018-12-20

Regulatory

• FDA-regulated device study