iNod System Human Feasibility Assessment

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02832284
• Collaborator: (none)
• Enrollment: 23
• Locations: 3
• Arm: 1
• Actual Duration (Months): 4.8
• Patients Per Site: 7.7
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule; Biopsy, Fine-Needle	Device: iNod System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions
• Actual Study Start Date: Jan 18, 2017
• Actual Primary Completion Date: Jun 8, 2017
• Actual Study Completion Date: Jun 14, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Visualization [Intraprocedural]

   Lesions visualized during iNod Maneuvers

3. Access [Intraprocedural]

   Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers

4. Acquisition [Intraprocedural]

   iNod maneuvers that acquired specimens of cellular matter for cytology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University Medical School	Baltimore	Maryland	United States	21287
2	Washington University of St. Louis	Saint Louis	Missouri	United States	63310
3	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Thomas Bowman, MD, Medical Director, Boston Scientific

Study Documents (Full-Text)

• Study Protocol - Mar 14, 2016
• Statistical Analysis Plan - Aug 12, 2016

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02832284
• Other Study ID Numbers: E7113
• First Posted: Jul 14, 2016
• Last Update Posted: Feb 11, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

Participant Flow

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
Period Title: Overall Study
STARTED	23
COMPLETED	23
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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. Per, protocol, each of the 23 enrolled subjects underwent evaluations with the iNod System. For study subjects for whom an adequate specimen, defined as a specimen that has been confirmed as suitable for cytologic evaluation, is not obtained from the iNod System diagnostic procedure but for whom continuation with endobronchial maneuvers are not contraindicated, additional standard of care (SOC) R-EBUS-guided diagnostic sampling maneuvers should be conducted.
Overall Participants	23
Overall Attepmts at target lesions	86
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68.0
Sex: Female, Male (Count of Participants)
Female	12 52.2%
Male	11 47.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	23 100%

Outcome Measures

1. Primary Outcome

Title	Acquisition of Adequate Specimens of Targeted Lung Lesions
Description	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.
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
Measure Participants	23
Count of Participants [Participants]	9 39.1%

2. Secondary Outcome

Title	Device/Procedure-Related Safety Events
Description	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.
Time Frame	Procedure through Post-procedure call; 6-8 days post-procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
Measure Participants	23
Count of Participants [Participants]	6 26.1%

3. Secondary Outcome

Title	Visualization
Description	Lesions visualized during iNod Maneuvers
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

Lesions visualized per attempt to visualize lesion

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
Measure Participants	23
Measure Lesions visualization attempts	86
Count of Units [Lesions visualization attempts]	72

4. Secondary Outcome

Title	Access
Description	Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

Lesions accessed per attempt to access lesion

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
Measure Participants	23
Measure Lesions access attempts	86
Count of Units [Lesions access attempts]	72

5. Secondary Outcome

Title	Acquisition
Description	iNod maneuvers that acquired specimens of cellular matter for cytology
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

Specimens of cellular matter for cytology per attempt, to acquire cellular matter.

Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
Measure Participants	23
Measure Specimens of cellular matter for cytolog	78
Count of Units [Specimens of cellular matter for cytolog]	69

Adverse Events

Time Frame	Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days.
Adverse Event Reporting Description	Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).
Arm/Group Title	iNod System
Arm/Group Description	Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 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.
All Cause Mortality
	iNod System
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Serious Adverse Events
	iNod System
	Affected / at Risk (%)	# Events
Total	2/23 (8.7%)
Infections and infestations
Pseudomonas Pneumonia	1/23 (4.3%)	1
Respiratory, thoracic and mediastinal disorders
Haemoptysis	1/23 (4.3%)	1
Other (Not Including Serious) Adverse Events
	iNod System
	Affected / at Risk (%)	# Events
Total	6/23 (26.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/23 (4.3%)	1
Cough	1/23 (4.3%)	1
Haemoptysis	4/23 (17.4%)	4
Oropharyngeal pain	2/23 (8.7%)	2

Limitations/Caveats

The study was not powered or designed as a study of diag. yield. Nor was this study designed to follow pts. with indeterminate cytology diagnoses. Non-malig. cytopathology. findings would require 6 mos. of follow-up (min. expect.) for a yield study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.