iNod™ Ultrasound-Guided Needle Biopsy System Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: iNod™ System Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System |
Device: iNod™ 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Real Time Visualization [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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older.
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Subject willing and able to comply with study procedures and provide written informed consent to participate in study.
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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.
- "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:
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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.
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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.
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Subjects with known coagulopathy.
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Subjects who are pregnant or nursing mothers.
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Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
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Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03766 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Alexander Chen, MD, Barnes-Jewish Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E7186