lung nodule identified on a CT scan which requires a biopsy procedure. Patients with a moderate to high risk of lung cancer
Conditions
Interventions
Patients with peripheral pulmonary nodule(s) measuring >=6 mm and
Sponsors
Intuitive Surgical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 =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
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) 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary performance endpoint: - Diagnostic yield of sample(s) obtained (post learning curve) - Sensitivity CUSUM analysis (learning curve) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance endpoint: - Sensitivity for malignancy of sample(s) obtained - Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging or the combination of multi-angle augmented fluoroscopy with rEBUS and diagnostic rapid onsite pathology (in the absence of a confirmatory spin). Safety endpoint: - Rate of procedure-related Adverse Events through 7 days post-procedure Exploratory endpoint: - Procedure-related characteristics: o Total number of imaging spins to obtain Tool in Nodule(s) as defined above o Number of catheter readjustments required to obtain Tool in Nodule(s) o Tool to nodule spatial relationship o Duration-related outcomes: - procedure time (from catheter inserted into the patient*s airways to catheter removed from the patient*s airways) - navigation time - time to rEBUS visualization - biopsy time o Number of additional interventional diagnostic procedures required post- procedure for a definitive diagnosis of the target nodule(s) o rEBUS visualization characteristics o Biopsy workflow, including but not limited to, sequence of biopsy tools used | — |
Countries
Netherlands
Outcome results
None listed