iNod™ Ultrasound-Guided Needle Biopsy System Study

NCT05804435 | Withdrawn FDA Device

• 1 other identifier: E7186
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Post-Market; Pulmonary Lesions; iNod; R-EBUS

Outcome Measures

Primary Outcomes (2)

• 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.

  Procedure

• 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.

  Procedure

Other Outcomes (4)

• Biopsy Yield

  Procedure

• Diagnostic Accuracy

  12 months post procedure

• Device Rotation

  Procedure

Study Arms (1)

iNod™ System

EXPERIMENTAL

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

Device: iNod™ System

Interventions

iNod™ System DEVICE

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.

Also known as: iNod™ Ultrasound Imaging System, iNod™ SUD

iNod™ System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Alexander Chen, MD

  Barnes-Jewish Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: January 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share