Clinical Utility for Ion Endoluminal System

PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System

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.

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