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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 and 1 month after the procedure. If the biopsy did not provide a diagnosis or did not show cancer, then they will have further follow up at 6 and 13 months.

Official Title
-----------------
A Prospective Investigation to Assess the Diagnostic Yield of Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure. 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. Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan. Patient with American Society of Anesthesiologists Classification (ASA) ≥4. Patient underwent a pneumonectomy. Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state. 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 has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, single-center, dual-arm, interventional study, where data from 131 recruited patients undergoing a Robotic Navigational Bronchoscopy System procedure with CBCT are compared to 91 matched Navigation Bronchoscopy with CBCT controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Navigational Bronchoscopy<br>Patients undergoing biopsy with the Ion Endoluminal System | Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging<br>* Biopsy with the Robotic- Navigational Bronchoscopy System with Cone Beam Computed Tomography (CBCT)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of sample(s) obtained (post learning curve) | Diagnostic yield is the number of nodules in which the procedure was diagnostic (either malignant or non-malignant), relative to the total number of attempted navigation procedures | Up to 13 months post procedure] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for malignancy of sample(s) obtained | Sensitivity for malignancy of samples is assessed as the number of subjects with a malignant condition determined through the study procedure (true positives) relative to the number of subjects with an underlying malignant disease state (true positives + false negatives). The subjects underlying disease state will be determined by follow-up diagnostic interventions or treatment decisions/interventions, and/or radiographic follow-up. | Up to 13 months post procedure | 
| Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging | The rate of Tool in Nodule is how often the biopsy tool to sample the tissue is positioned directly within the nodule before the sample is taken. If biopsy forceps are used, it is how often the instrument is surrounding the nodule before the sample is taken. | At time of the biopsy procedure (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biopsy, Lung Cancer, Bronchoscopy