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iNod™ Ultrasound-Guided Needle Biopsy System Study

Primary Purpose

Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Biopsy, Fine-Needle

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iNod™ System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Solitary Pulmonary Nodule focused on measuring Post-Market, Pulmonary Lesions, iNod, R-EBUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 years or older. Subject willing and able to comply with study procedures and provide written informed consent to participate in study. Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) 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 at least 80% of the lesion. a. "Peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope. 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 or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT. Subjects who have medical contraindication to undergo conventional flexible or robotic 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. Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy

Sites / Locations

  • Dartmouth-Hitchcock Medical Center
  • Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iNod™ System

Arm Description

Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System

Outcomes

Primary Outcome Measures

Proportion of patients where the needle is visualized by the iNOD system inside the lesion
Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.
Adverse Events
Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2023
Last Updated
September 27, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05804435
Brief Title
iNod™ Ultrasound-Guided Needle Biopsy System Study
Official Title
Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
Detailed Description
This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Biopsy, Fine-Needle
Keywords
Post-Market, Pulmonary Lesions, iNod, R-EBUS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iNod™ System
Arm Type
Experimental
Arm Description
Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System
Intervention Type
Device
Intervention Name(s)
iNod™ System
Other Intervention Name(s)
iNod™ Ultrasound Imaging System, iNod™ SUD
Intervention Description
The iNod™ Ultrasound Imaging System enables visualization of endobronchial lesions, peripheral lung nodules, or lung masses (referred to as lesions) using R-EBUS and performance of lung biopsy under direct R-EBUS visualization.
Primary Outcome Measure Information:
Title
Proportion of patients where the needle is visualized by the iNOD system inside the lesion
Description
Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.
Time Frame
Procedure
Title
Adverse Events
Description
Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures.
Time Frame
Procedure
Other Pre-specified Outcome Measures:
Title
Biopsy Yield
Description
Diagnostic biopsy yield, defined as ability for histopathologist to report a specific benign or malignant diagnosis, stratified by concentric and eccentric lesion location.
Time Frame
Procedure
Title
Diagnostic Accuracy
Description
Diagnostic accuracy at 12 months.
Time Frame
12 months post procedure
Title
Device Rotation
Description
Ability to reposition the needle into a different location within targeted lesions, if desired.
Time Frame
Procedure
Title
Crossover Rate
Description
Crossover rate to radial EBUS or any alternative standard of care procedure.
Time Frame
Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. Subject willing and able to comply with study procedures and provide written informed consent to participate in study. Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) 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 at least 80% of the lesion. a. "Peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope. 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 or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT. Subjects who have medical contraindication to undergo conventional flexible or robotic 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. Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria E Lazzari
Phone
1508-382-9132
Email
victoria.lazzari@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Chen, MD
Organizational Affiliation
Barnes-Jewish Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Whitley
First Name & Middle Initial & Last Name & Degree
David Feller-Kopman, MD
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Miller
First Name & Middle Initial & Last Name & Degree
Nicholas Pastis, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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iNod™ Ultrasound-Guided Needle Biopsy System Study

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