iNod™ Ultrasound-Guided Needle Biopsy System Study
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Biopsy, Fine-Needle
About this trial
This is an interventional diagnostic trial for Solitary Pulmonary Nodule focused on measuring Post-Market, Pulmonary Lesions, iNod, R-EBUS
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. Subject willing and able to comply with study procedures and provide written informed consent to participate in study. Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) 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 at least 80% of the lesion. a. "Peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope. 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 or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT. Subjects who have medical contraindication to undergo conventional flexible or robotic 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. Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
Sites / Locations
- Dartmouth-Hitchcock Medical Center
- Ohio State University Wexner Medical Center
Arms of the Study
Arm 1
Experimental
iNod™ System
Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System