NCT02832284: iNod

iNod System Human Feasibility Assessment

Completed NA Results posted Last updated 11 February 2021

What this trial tests

NA trial testing iNod System in Solitary Pulmonary Nodule in 23 participants. Completed in 14 June 2017.

Timeline

18 January 2017

Primary endpoint
8 June 2017

14 June 2017

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	23
Start date	18 January 2017
Primary completion	8 June 2017
Estimated completion	14 June 2017
Sites	3 locations across United States

Drugs / interventions tested

• iNod System

Conditions studied

• Solitary Pulmonary Nodule — all drugs for Solitary Pulmonary Nodule →
• Biopsy, Fine-Needle — all drugs for Biopsy, Fine-Needle →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Solitary Pulmonary Nodule or Biopsy, Fine-Needle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acquisition of Adequate Specimens of Targeted Lung Lesions Primary · 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.

Group	Value	95% CI
iNod System	9

Device/Procedure-Related Safety Events Secondary · 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.

Group	Value	95% CI
iNod System	6

Visualization Secondary · Intraprocedural

Lesions visualized during iNod Maneuvers

Group	Value	95% CI
iNod System	72

Access Secondary · Intraprocedural

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

Group	Value	95% CI
iNod System	72

Acquisition Secondary · Intraprocedural

iNod maneuvers that acquired specimens of cellular matter for cytology

Group	Value	95% CI
iNod System	69

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

iNod System

Serious: 2/23 (9%)

Deaths: 0/23

Serious adverse events (2 terms)

Reaction	System	iNod System
Pseudomonas Pneumonia	Infections and infestations	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	iNod System
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Pseudomonas Pneumonia, Haemoptysis.

Data from ClinicalTrials.gov NCT02832284 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. First-in-Human Use of a Hybrid Real-Time Ultrasound-Guided Fine-Needle Acquisition System for Peripheral Pulmonary Lesions: A Multicenter Pilot Study.
   Yarmus LB, Mallow C, Pastis N, Thiboutot J, et al · · 2019 · cited 15× · PMID 31707384 · DOI 10.1159/000504025