An interventional study of iNod System in Solitary Pulmonary Nodule and Biopsy, Fine-Needle, sponsored by Boston Scientific Corporation. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Diagnostic
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.
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.
188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's enrollment of 23 is below the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Visualization
Lesions visualized during iNod Maneuvers
Time frame: Intraprocedural
Access
Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers
Time frame: Intraprocedural
Acquisition
iNod maneuvers that acquired specimens of cellular matter for cytology
Time frame: Intraprocedural
| Milestone | iNod System |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
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.
| Participants | iNod System |
|---|---|
| Acquisition of Adequate Specimens of Targeted Lung Lesions | 9 |
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.
| Participants | iNod System |
|---|---|
| Device/Procedure-Related Safety Events | 6 |
Lesions visualized during iNod Maneuvers
| Lesions visualization attempts | iNod System |
|---|---|
| Visualization | 72 |
Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers
| Lesions access attempts | iNod System |
|---|---|
| Access | 72 |
iNod maneuvers that acquired specimens of cellular matter for cytology
| Specimens of cellular matter for cytolog | iNod System |
|---|---|
| Acquisition | 69 |
Collected over Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iNod System | 0/23 (0%) | 2/23 (8.7%) | 6/23 (26.1%) |
| Event | iNod System |
|---|---|
| Pseudomonas PneumoniaInfections and infestations | 1/23 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 1/23 |
| Event | iNod System |
|---|---|
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 4/23 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/23 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 1/23 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/23 |
23 Patients were analyzed for primary endpoint. 86 Attempts to access target lesions were analyzed.
| Age, Continuous(years) | iNod System |
|---|---|
| Mean | 68.0 (48.0 to 89.0) |
| Sex: Female, Male(Participants) | iNod System |
|---|---|
| Female | 12 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | iNod System |
|---|
| Region of Enrollment(participants) | iNod System |
|---|---|
| United States | 23 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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).
Supporting information: Study protocol, Sap
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