iNod System Human Feasibility Assessment

Not Applicable

Completed

• Conditions: Biopsy, Fine-Needle; Solitary Pulmonary Nodule
• Interventions: Device: iNod System

• Registration Number: NCT02832284
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Study Start: 2017-01-18
• Primary Completion: 2017-06-08
• Study Completion: 2017-06-14
• Results First Submitted: 2018-09-11
• Results First Submitted QC: 2018-10-25
• Results First Posted: 2018-11-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iNod System	iNod System	Multi-center, Prospective, Single-arm Feasibility Study with Salvage.

Primary Outcome Measures

Name	Time	Method
Acquisition of Adequate Specimens of Targeted Lung Lesions	Intraprocedural	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

Name	Time	Method
Visualization	Intraprocedural	Lesions visualized during iNod Maneuvers
Device/Procedure-Related Safety Events	Procedure through Post-procedure call; 6-8 days post-procedure.	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.
Acquisition	Intraprocedural	iNod maneuvers that acquired specimens of cellular matter for cytology
Access	Intraprocedural	Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers

Trial Locations

Locations (3)

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, United States