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

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.

Study Overview

• Status: Completed
• Conditions: Solitary Pulmonary Nodule; Biopsy, Fine-Needle
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Medical School
  • Missouri
    • Saint Louis, Missouri, United States, 63310
      • Washington University of St. Louis
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iNod System; Multi-center, Prospective, Single-arm Feasibility Study with Salvage.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Procedure through Post-procedure call; 6-8 days post-procedure.
Visualization	Lesions visualized during iNod Maneuvers	Intraprocedural
Access	Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers	Intraprocedural
Acquisition	iNod maneuvers that acquired specimens of cellular matter for cytology	Intraprocedural

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Thomas Bowman, MD, Medical Director, Boston Scientific

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: E7113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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).
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes