Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447482
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2020-05-08
Brief Title:
ENB Vs Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
Sponsor:
Shanghai Youhe Medical Technology Co Ltd
Organization:
Shanghai Youhe Medical Technology Co Ltd
Study Overview
Official Title:
A Prospective Randomized Multi-center Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy 4D-ENB versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer
Detailed Description:
The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated This is a prospective randomized multi-center study
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?:
True
Is an FDA AA801 Violation?:
None