iNod System Human Feasibility Assessment

NCT ID: NCT02832284

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2017-06-14

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.

Conditions

Solitary Pulmonary Nodule; Biopsy, Fine-Needle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

iNod System

Multi-center, Prospective, Single-arm Feasibility Study with Salvage.

Group Type: EXPERIMENTAL

iNod System

Intervention Type: DEVICE

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.

Interventions

iNod System

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Bowman, MD

Role: STUDY_DIRECTOR

Medical Director, Boston Scientific

Locations

Johns Hopkins University Medical School

Baltimore, Maryland, United States

Washington University of St. Louis

St Louis, Missouri, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

E7113

Identifier Type: -

Identifier Source: org_study_id