Robotic Bronchoscopy for Peripheral Pulmonary Lesions
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.
Checked against the public recordLast updated Dec 14, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Auris Health, Inc.
- Interventions being studied
- Device: Robotic assisted bronchoscopy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Capable and willing to give informed consent 2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure 3. 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 4. Lack bleeding disorders Exclusion Criteria: 1. Medical contraindication to bronchoscopy 2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT 3. Patients with endobronchial involvement seen on chest CT 4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure 5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study 6. Uncontrolled or irreversible coagulopathy 7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test 8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Henry Ford Health SystemDetroit, Michigan
- Washington University School of MedicineSt Louis, Missouri
- Cleveland ClinicCleveland, Ohio
- Medical University of South CarolinaCharleston, South Carolina
- Innova Fairfax HospitalFalls Church, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 14, 2020. Always confirm current availability with the study team.