Ensayos clínicos

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.

• (**) For stage 0 only, subjects must have a Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3.5cm in largest dimension.

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., 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 (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) performed in the same lobe as the target nodule(s).
• Previous surgical intervention (i.e., wedge resection or lobectomy) on ipsilateral side of 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.