cios mobile 3d spin for robotic bronchoscopy

Conditions: Pulmonary Nodule, Solitary; Pulmonary Cancer; Lung Cancer; Lung Cancer, Nonsmall Cell; Lung Adenocarcinoma

Summary: evaluate the clinical utility and early performance of the cios 3d mobile spin in conjunction with the ion endoluminal system, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.


Eligibility criteria:
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)