Biopsy, Fine-Needle, Solitary Pulmonary Nodule
Conditions
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.
Interventions
DEVICEiNod 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Visualization | Intraprocedural | Lesions visualized during iNod Maneuvers |
| Access | Intraprocedural | Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers |
| Acquisition | Intraprocedural | iNod maneuvers that acquired specimens of cellular matter for cytology |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iNod System 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. | 23 |
| iNod System 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. | 86 |
| Total | 109 |
Baseline characteristics
| Characteristic | iNod System |
|---|---|
| Age, Continuous | 68.0 years |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 6 / 23 |
| serious Total, serious adverse events | 2 / 23 |
Outcome results
Primary
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.
Time frame: Intraprocedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iNod System | Acquisition of Adequate Specimens of Targeted Lung Lesions | 9 Participants |
Secondary
Access
Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers
Time frame: Intraprocedural
Population: Lesions accessed per attempt to access lesion
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| iNod System | Access | 72 Lesions access attempts |
Secondary
Acquisition
iNod maneuvers that acquired specimens of cellular matter for cytology
Time frame: Intraprocedural
Population: Specimens of cellular matter for cytology per attempt, to acquire cellular matter.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| iNod System | Acquisition | 69 Specimens of cellular matter for cytolog |
Secondary
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.
Time frame: Procedure through Post-procedure call; 6-8 days post-procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iNod System | Device/Procedure-Related Safety Events | 6 Participants |
Secondary
Visualization
Lesions visualized during iNod Maneuvers
Time frame: Intraprocedural
Population: Lesions visualized per attempt to visualize lesion
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| iNod System | Visualization | 72 Lesions visualization attempts |