Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04571476
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2020-09-26
Brief Title:
Diagnostic Value of UTB and TB for PPL
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions A Prospective Randomized Controlled Multicenter Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
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:
The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope UTB and TB for peripheral pulmonary lesions PPLs without X-ray fluoroscopy
Detailed Description:
The study aims to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope UTB and TB with the guidance of virtual bronchoscopic navigation VBN combined with endobronchial ultrasound EBUS for peripheral pulmonary lesions PPLs without X-ray fluoroscopy The study is designed as a prospective multicenter randomized controlled clinical trial The participating centers are The First Affiliated Hospital of Guangzhou Medical University Cancer Hospital Chinese Academy of Medical Sciences West China Hospital Sichuan University and Henan Provincial Peoples Hospital Patients are divided into three groups UTB-VBN-EBUS group TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group Each subject will be randomized to each group The study is expected to enroll a total of 577 patients with 193 192 and 192 in UTB-VBN-EBUS group TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None