Cios Mobile 3D Spin for Robotic Bronchoscopy

Inclusion criteria

• Subject age 18 years and older
• Subject is suitable for elective bronchoscopy
• Subject with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
• Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤3.5 cm in largest dimension
• Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus)
• Subject is a candidate for CT-guided needle biopsy
• Subject is able to understand and adhere to study requirements
• Subject is able to understand and adhere to study requirements and able to provide informed consent
• Subject is not legally incapacitated or in legal/court ordered institution
• Subject has no dependency on the investigator or sponsor

Exclusion criteria

• Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
• Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
• Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
• Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e. > 30 breaths per minute) per physician assessment
• Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
• World Health Organization functional Class IV Pulmonary Hypertension or history of clinically significant mPAP
• Known or suspected pregnancy
• Recent head injury (<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits
• Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness)
• Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 88% or requiring >4L of oxygen prior to procedure)
• Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of major bleeding with bronchoscopy
• Subjects contraindicated for intubation or general anesthesia, or subjects with ASA ≥ 5
• Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e. heparin or warfarin) or /platelet aggression inhibitors (i.e. Abciximac or Eptifibatide) medications that cannot be stopped per standard practice, i.e. 5-7 days pre-procedure or heparin that cannot be held according to standard practice (6-12 hours). Aspirin not included.
• Any severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy
• Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
• Endobronchial lesion associated with lobar atelectasis
• Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
• Non-systemic treatment for lung cancer (i.e. SBRT) performed in the same lobe as the target nodule(s)
• Previous surgical intervention performed in the same lobe as the target nodule (s)