Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT

A Prospective Investigation to Assess the Diagnostic Yield of 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. The learning curve of the procedure will be assessed and data on safety will also be collected.

This is a prospective, interventional, single-centre, dual-arm study which will be conducted in the Netherlands and will involve up to 131 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. Outcomes in these patients will be compared to 91 propensity score matched Cone Beam CT- Navigational Bronchoscopy (CBCT-NB) controls obtained from the site's existing CBCT-NB database.

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

A learning curve analysis will be retrospectively performed to determine when both operators have reached competency with the Ion Endoluminal System. Criteria for passing the learning curve for measuring proficiency in the CUSUM will be diagnostic yield. Additional parameters like tool in lesion and procedure durations will also be monitored.

All subjects will be followed up at 1 week after the procedure. If an adverse event was observed, a 30-day post-procedure visit will also take place. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) and the nodule is still under observation, 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 bullae(s) with a size of >1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments.
4. Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
5. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
6. Patient underwent a pneumonectomy.
7. Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state.
8. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
9. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
10. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
11. 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.
12. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
13. Patient is not willing to comply with post study procedure participation requirements.