Cios Mobile 3D Spin for Robotic Bronchoscopy

Study Overview
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Brief Summary
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Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.

Official Title
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Cios Mobile 3D Spin for Robotic Bronchoscopy

Conditions
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Pulmonary Nodule, Solitary, Pulmonary Cancer, Lung Cancer, Lung Cancer, Nonsmall Cell, Lung Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: Ion Endoluminal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject age 18 years and older Subject is suitable for elective bronchoscopy Subject with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤3.5 cm in largest dimension Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus) Subject is a candidate for CT-guided needle biopsy Subject is able to understand and adhere to study requirements Subject is able to understand and adhere to study requirements and able to provide informed consent Subject is not legally incapacitated or in legal/court ordered institution Subject has no dependency on the investigator or sponsor Exclusion Criteria: Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e. > 30 breaths per minute) per physician assessment Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C) World Health Organization functional Class IV Pulmonary Hypertension or history of clinically significant mPAP Known or suspected pregnancy Recent head injury (<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness) Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 88% or requiring >4L of oxygen prior to procedure) Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of major bleeding with bronchoscopy Subjects contraindicated for intubation or general anesthesia, or subjects with ASA ≥ 5 Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e. heparin or warfarin) or /platelet aggression inhibitors (i.e. Abciximac or Eptifibatide) medications that cannot be stopped per standard practice, i.e. 5-7 days pre-procedure or heparin that cannot be held according to standard practice (6-12 hours). Aspirin not included. Any severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician Endobronchial lesion associated with lobar atelectasis Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA) Non-systemic treatment for lung cancer (i.e. SBRT) performed in the same lobe as the target nodule(s) Previous surgical intervention performed in the same lobe as the target nodule (s)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary Nodule<br>Pulmonary nodule is suitable for elective bronchoscopy with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease. | Diagnostic Test: Ion Endoluminal System<br>* Robotic bronchoscopy with c-arm imaging.<br>* Other names: Cios 3D mobile spin system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tool in Lesion | Ability to visualize on 3D imaging the pre-planned target location characterized when displayed distance of catheter tip to nearest edge of the virtual target is ≤ 2cm and is oriented towards the lesion in 3 axes. | At the time of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related complications | Overall incidence of procedure-related complications recorded as adverse events. | 6 months | 
| Duration-related outcomes | Reporting of times related to procedure times including procedure time, navigation time, time to 3D confirmation, time to tissue acquisitions, anesthesia time, and fluoroscopy time and dose. | At the time of the procedure |