iNod System Human Feasibility Assessment
iNod
Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions
1 other identifier
interventional
23
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedStudy Start
First participant enrolled
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2017
CompletedResults Posted
Study results publicly available
November 23, 2018
CompletedFebruary 11, 2021
January 1, 2021
5 months
June 27, 2016
September 11, 2018
January 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Device/Procedure-Related Safety Events
Procedure through Post-procedure call; 6-8 days post-procedure.
Visualization
Intraprocedural
Access
Intraprocedural
Acquisition
Intraprocedural
Study Arms (1)
iNod System
EXPERIMENTALMulti-center, Prospective, Single-arm Feasibility Study with Salvage.
Interventions
The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Johns Hopkins University Medical School
Baltimore, Maryland, 21287, United States
Washington University of St. Louis
St Louis, Missouri, 63310, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was not powered or designed as a study of diag. yield. Nor was this study designed to follow pts. with indeterminate cytology diagnoses. Non-malig. cytopathology. findings would require 6 mos. of follow-up (min. expect.) for a yield study.
Results Point of Contact
- Title
- G Mark Grubb, RN, CCRA
- Organization
- Boston Scientific Corporation
Study Officials
- STUDY DIRECTOR
Thomas Bowman, MD
Medical Director, Boston Scientific
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2016
First Posted
July 14, 2016
Study Start
January 18, 2017
Primary Completion
June 8, 2017
Study Completion
June 14, 2017
Last Updated
February 11, 2021
Results First Posted
November 23, 2018
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-policy.html).
- Access Criteria
- The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-policy.html).
The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-policy.html).