Solitary Pulmonary Nodule Clinical Trial
— iNodOfficial title:
Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions
NCT number | NCT02832284 |
Other study ID # | E7113 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 18, 2017 |
Est. completion date | June 14, 2017 |
Verified date | January 2021 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | June 14, 2017 |
Est. primary completion date | June 8, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is age 18 years or older. 2. Subject is willing and able to comply with study procedures and provide written informed consent to participate in study. 3. 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. 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, a subsolid target lesion, and/or a ground glass opacity identified on Chest CT. 2. Subjects with lesions that include endobronchial involvement, per Chest CT. 3. Subjects who lack fitness to undergo flexible bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator. 4. Subjects with known coagulopathy. 5. Subjects who are pregnant or nursing mothers. 6. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University Medical School | Baltimore | Maryland |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Washington University of St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acquisition of Adequate Specimens of Targeted Lung Lesions | The primary endpoint for the iNod Feasibility Study was clinical success, defined as the iNod System's ability to acquire adequate specimens of cellular matter suitable for the cytologic evaluation of targeted lung lesions, under real-time visualization. | Intraprocedural | |
Secondary | Device/Procedure-Related Safety Events | Occurrence and severity of Adverse Events related to the iNod System biopsy procedures, as well as Adverse Events related to any subsequent Radial EBUS-guided salvage procedures. | Procedure through Post-procedure call; 6-8 days post-procedure. | |
Secondary | Visualization | Lesions visualized during iNod Maneuvers | Intraprocedural | |
Secondary | Access | Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers | Intraprocedural | |
Secondary | Acquisition | iNod maneuvers that acquired specimens of cellular matter for cytology | Intraprocedural |
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