Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Completed · Not applicable

Conditions studied: Lung; Node

In brief

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Key facts

Study ID

NCT03727425

Run by

Auris Health, Inc.

People needed

55

Starts

2018-11-01

Expected to finish

2020-06-30

Last updated by the study team

2020-12-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable and willing to give informed consent
• Acceptable candidate for an elective, non-emergent bronchoscopic procedure
• Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
• Lack bleeding disorders

You may not qualify if…

• Medical contraindication to bronchoscopy
• Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
• Patients with endobronchial involvement seen on chest CT
• Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
• Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
• Uncontrolled or irreversible coagulopathy
• Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
• Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

Where it is running

• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Innova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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