Trials / Withdrawn
WithdrawnNCT05804435
iNod™ Ultrasound-Guided Needle Biopsy System Study
Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2026-02-01
- Completion
- 2027-02-01
- First posted
- 2023-04-07
- Last updated
- 2024-03-08
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05804435. Inclusion in this directory is not an endorsement.