iNod™ Ultrasound-Guided Needle Biopsy System Study
NCT05804435 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-03-08
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
Interventions
- DEVICE
-
iNod™ System
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.
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Alexander Chen, MD · Barnes-Jewish Hospital
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-31
- Primary Completion
- 2026-02-28
- Completion
- 2027-02-28
- FDA Device
- Yes
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