Back to resultsiNod System Human Feasibility Assessment (iNod)
Primary Purpose
Solitary Pulmonary Nodule, Biopsy, Fine-Needle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iNod System
Sponsored by
About this trial
This is an interventional diagnostic trial for Solitary Pulmonary Nodule
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.
Sites / Locations
- Johns Hopkins University Medical School
- Washington University of St. Louis
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iNod System
Arm Description
Multi-center, Prospective, Single-arm Feasibility Study with Salvage.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Visualization
Lesions visualized during iNod Maneuvers
Access
Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers
Acquisition
iNod maneuvers that acquired specimens of cellular matter for cytology
Full Information
NCT ID
NCT02832284
First Posted
June 27, 2016
Last Updated
January 27, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02832284
Brief Title
iNod System Human Feasibility Assessment
Acronym
iNod
Official Title
Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This protocol is a traditional feasibility study for the sampling of a peripheral pulmonary lesion in the setting of a suspicion of lung cancer. Standard of practice radial endobronchial ultrasound (R-EBUS) transbronchial needle aspiration (TBNA) is visualizing a peripheral lesion on R-EBUS, locking the placement of the access sheath, removing the ultrasound catheter from the access sheath and then blindly advancing a sampling device to acquire cellular matter for cytologic evaluation. The iNod system performs the same procedure with one fewer device exchange. It provides real-time visualization of the biopsy needle and target peripheral pulmonary lesions during tissue acquisition. The ultrasound probe is not retracted in advance of the sampling maneuver and the sampling is completed under direct visualization. Compared to current standard of care methods for transbronchial sampling of pulmonary lesions, this approach is not expected to add additional risk. Tissue sampling under real-time visualization may improve the efficiency of tissue sampling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Biopsy, Fine-Needle
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iNod System
Arm Type
Experimental
Arm Description
Multi-center, Prospective, Single-arm Feasibility Study with Salvage.
Intervention Type
Device
Intervention Name(s)
iNod System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acquisition of Adequate Specimens of Targeted Lung Lesions
Description
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.
Time Frame
Intraprocedural
Secondary Outcome Measure Information:
Title
Device/Procedure-Related Safety Events
Description
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.
Time Frame
Procedure through Post-procedure call; 6-8 days post-procedure.
Title
Visualization
Description
Lesions visualized during iNod Maneuvers
Time Frame
Intraprocedural
Title
Access
Description
Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers
Time Frame
Intraprocedural
Title
Acquisition
Description
iNod maneuvers that acquired specimens of cellular matter for cytology
Time Frame
Intraprocedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bowman, MD
Organizational Affiliation
Medical Director, Boston Scientific
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins University Medical School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington University of St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63310
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing 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).
IPD Sharing 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).
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iNod System Human Feasibility Assessment
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