Clinical Utility for Ion Endoluminal System

Inclusion Criteria:

Patients aged 18 years and older
Patient is suitable for elective bronchoscopy
Patients 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 ≤ 3cm in largest dimension
Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*
Patients are candidates for CT-guided needle biopsy and/or surgical resection
Patient able to understand and adhere to study requirements
Patient able to understand and adhere to study requirements and able to provide informed consent
Patient not legally incapacitated or in legal/court ordered institution
Patients with 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 III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
Lung abscess
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)
Subjects with pure ground glass opacity target nodule
Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 92% 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 ≥ 4
Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e heparin or warfarin) or platelet aggression inhibitors (i.e. Abciximab 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 (i.e. >Stage 3 heart failure)
Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
Endobronchial lesion associated with lobar atelectasis
Presence of bullae >1cm located within a cone based trajectory of biopsy instruments or in location presenting risk per physician assessment
Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
Subjects taking the following medications: Immunosuppressive treatment with systemic azathioprine, Cyclosporine, antibodies or cytostatics, other chemotherapeutic agents or medications acting on immunophilins
Non-systemic treatment for lung cancer (i.e. SBRT, ablation) performed in the same lobe as the target nodule(s)
Previous surgical intervention (i.e. wedge resection or lobectomy) within the same lobe as target nodule (s)
Participation in any interventional clinical study or clinical study with experimental agents or agents of unknown risk in last 30 days prior to screening