Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05804435
Status:
WITHDRAWN
Last Update Posted:
2024-03-08
First Post:
2023-03-27
Brief Title:
iNod Ultrasound-Guided Needle Biopsy System Study
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect information on the iNod Systems 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None