iNod System Human Feasibility Assessment

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02832284
Study type	Interventional
Source	Boston Scientific Corporation
Contact
Status	Completed
Phase	N/A
Start date	January 18, 2017
Completion date	June 14, 2017

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iNod System Human Feasibility Assessment — iNod

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms