iNod System Human Feasibility Assessment

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate feasibility to access, visualize, and obtain specimens adequate for cytology of lung lesions in subjects with suspected lung cancer when using the iNod System.

Detailed Description
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This protocol is a traditional feasibility study for the sampling of a peripheral pulmonary lesion in the setting of a suspicion of lung cancer. Standard of practice radial endobronchial ultrasound (R-EBUS) transbronchial needle aspiration (TBNA) is visualizing a peripheral lesion on R-EBUS, locking the placement of the access sheath, removing the ultrasound catheter from the access sheath and then blindly advancing a sampling device to acquire cellular matter for cytologic evaluation. The iNod system performs the same procedure with one fewer device exchange. It provides real-time visualization of the biopsy needle and target peripheral pulmonary lesions during tissue acquisition. The ultrasound probe is not retracted in advance of the sampling maneuver and the sampling is completed under direct visualization. Compared to current standard of care methods for transbronchial sampling of pulmonary lesions, this approach is not expected to add additional risk. Tissue sampling under real-time visualization may improve the efficiency of tissue sampling.

Official Title
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Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions

Conditions
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Solitary Pulmonary Nodule, Biopsy, Fine-Needle

Intervention / Treatment
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* Device: iNod System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is age 18 years or older. Subject is willing and able to comply with study procedures and provide written informed consent to participate in study. Subject with a predominantly solid lung lesion, 1 cm to 7 cm in diameter, which has been identified on chest CT (obtained within 6 weeks) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. If the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up 80% of the lesion. Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject. Exclusion Criteria: Subjects with pure ground glass opacity, a subsolid target lesion, and/or a ground glass opacity identified on Chest CT. Subjects with lesions that include endobronchial involvement, per Chest CT. Subjects who lack fitness to undergo flexible bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator. Subjects with known coagulopathy. Subjects who are pregnant or nursing mothers. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

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: iNod System<br>Multi-center, Prospective, Single-arm Feasibility Study with Salvage. | Device: iNod System<br>* The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition of Adequate Specimens of Targeted Lung Lesions | The primary endpoint for the iNod Feasibility Study was clinical success, defined as the iNod System's ability to acquire adequate specimens of cellular matter suitable for the cytologic evaluation of targeted lung lesions, under real-time visualization. | Intraprocedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device/Procedure-Related Safety Events | Occurrence and severity of Adverse Events related to the iNod System biopsy procedures, as well as Adverse Events related to any subsequent Radial EBUS-guided salvage procedures. | Procedure through Post-procedure call; 6-8 days post-procedure. | 
| Visualization | Lesions visualized during iNod Maneuvers | Intraprocedural | 
| Access | Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers | Intraprocedural | 
| Acquisition | iNod maneuvers that acquired specimens of cellular matter for cytology | Intraprocedural |