Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System

Korábbi kezelés

• Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
• Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state.
• Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.

Laborértékek

• Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.

Egyéb

• Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
• Presence of mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
• Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
• Patient underwent a pneumonectomy.
• Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
• Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation.
• Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
• Patient is not willing to comply with post study procedure participation requirements.

• Patient is aged 18 years or older at time of consent.
• Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
• Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
• Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan.
• Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention.
• Patient is willing and able to give written informed consent for Clinical Investigation participation.
• Patient is not legally incapacitated or in a legal/court ordered institution.