Electromagnetic Navigation for Peripheral Pulmonary Lesions

Study Overview
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Brief Summary
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Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.

Official Title
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Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance

Conditions
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Peripheral Lung Lesions

Intervention / Treatment
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* Device: Olympus BF-180 bronchoscope (standard adult)
* Device: Veran Spinview Thoracic Navigation System
* Device: Olympus UM-S20-17S
* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. Are at least 18 years old Are able to provide informed consent Exclusion Criteria: Patients who refuse to participate Are less than 18 years of age Are pregnant Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist Are unable to provide informed consent

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Electromagnetic navigation<br>The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed. Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree. Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation. Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles. | Device: Olympus BF-180 bronchoscope (standard adult)<br>* -Standard of care<br>Device: Veran Spinview Thoracic Navigation System<br>* -Electromagnetic navigation<br>Device: Olympus UM-S20-17S<br>* -Endobronchial ultrasound mini-probe<br>Procedure: Biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance | -Primary outcome of diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive. | At the time of procedure (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of successful navigation by using radial probe endobronchial ultrasound |  | At the time of procedure (1 day) | 
| Safety as measured by adverse event rates | -Pneumothorax will be documented by post-biopsy CXR or chest ultrasonography, and the number requiring intervention, such as chest tube placement, will be recorded. Significant hemoptysis will be defined as bleeding noted at the time of procedure that requires a change in the level of care (e.g. outpatient to inpatient or inpatient to ICU) or a blood transfusion. Other adverse events that are common to bronchoscopy will be monitored | At the time of procedure (1 day) |