N/A
N=23
iNod System Human Feasibility Assessment
Solitary Pulmonary Nodule · Biopsy, Fine-Needle
Bottom Line
View on ClinicalTrials.gov: NCT02832284 ↗Enrolled (actual)
23
Serious AEs
8.7%
Results posted
Nov 2018
Primary outcome: Primary: Acquisition of Adequate Specimens of Targeted Lung Lesions — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iNod System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acquisition of Adequate Specimens of Targeted Lung Lesions |
9 | — |
| SECONDARY Device/Procedure-Related Safety Events |
6 | — |
| SECONDARY Visualization |
72 | — |
| SECONDARY Access |
72 | — |
| SECONDARY Acquisition |
69 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02832284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.