clinical utility for ion endoluminal system

Conditions: Pulmonary Nodule; Lung Cancer; Lung Diseases

Summary: the goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the fda-cleared ion™ endoluminal system ("ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.


Eligibility criteria:
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