iNod System Human Feasibility Assessment
Completed · Not applicable
Conditions studied: Solitary Pulmonary Nodule, Biopsy, Fine-Needle
In brief
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.
Key facts
- Study ID
- NCT02832284
- Run by
- Boston Scientific Corporation
- People needed
- 23
- Starts
- 2017-01-18
- Expected to finish
- 2017-06-14
- Last updated by the study team
- 2021-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins University Medical School — Baltimore, Maryland, United States
- Washington University of St. Louis — St Louis, Missouri, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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