Cios Mobile 3D Spin for Robotic Bronchoscopy

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)