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

A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging

The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. Data on safety will also be collected.

This is a prospective, interventional, multicentre, single arm study which will be conducted in Europe and will involve up to 200 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging.

The objectives of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including rate of tool in nodule, diagnostic accuracy, sensitivity for malignancy and safety.

All subjects will be followed up at 1 week and 1 month after the procedure. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation at the 1 month visit, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) at 6 months, the patients a 13 months visit should be completed.

Inclusion Criteria:

1. Patient is aged 18 years or older at time of consent.
2. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
3. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
4. 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.
5. 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.
6. Patient is willing and able to give written informed consent for Clinical Investigation participation.
7. Patient is not legally incapacitated or in a legal/court ordered institution.

Exclusion Criteria:

1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
2. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
3. Presence of mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
4. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
5. Patient underwent a pneumonectomy.
6. Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state.
7. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
8. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
9. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
10. 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.
11. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
12. Patient is not willing to comply with post study procedure participation requirements.