Biopsy, Fine-Needle, Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
Conditions
Keywords
Post-Market, Pulmonary Lesions, iNod, R-EBUS
Brief summary
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
Detailed description
This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.
Interventions
DEVICEiNod™ System
The iNod™ Ultrasound Imaging System enables visualization of endobronchial lesions, peripheral lung nodules, or lung masses (referred to as lesions) using R-EBUS and performance of lung biopsy under direct R-EBUS visualization.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older. 2. Subject willing and able to comply with study procedures and provide written informed consent to participate in study. 3. 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. 4. Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject.
Exclusion criteria
1. 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. 2. 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. 3. Subjects with known coagulopathy. 4. Subjects who are pregnant or nursing mothers. 5. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. 6. Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients where the needle is visualized by the iNOD system inside the lesion | Procedure | Successful Tool in lesion, defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view. |
| Adverse Events | Procedure | Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biopsy Yield | Procedure | Diagnostic biopsy yield, defined as ability for histopathologist to report a specific benign or malignant diagnosis, stratified by concentric and eccentric lesion location. |
| Diagnostic Accuracy | 12 months post procedure | Diagnostic accuracy at 12 months. |
| Device Rotation | Procedure | Ability to reposition the needle into a different location within targeted lesions, if desired. |
| Crossover Rate | Procedure | Crossover rate to radial EBUS or any alternative standard of care procedure. |
Outcome results
None listed