Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597346
Status:
RECRUITING
Last Update Posted:
2023-02-23
First Post:
2020-10-14
Brief Title:
Evaluate the Diagnostic Value of BTPNA for PPL a Real-world Study
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
A Single-arm Prospective Multicenter Real-world Study to Evaluate the Safety and Efficacy of Bronchoscopic Transparenchymal Nodule Access BTPNA for the Diagnosis of Peripheral Lung Lesions
Status:
RECRUITING
Status Verified Date:
2023-02
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 study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate
Detailed Description:
The study will be conducted at about 10 clinical centers Patients will be first screened and only after meeting all the selection criteria not meeting any exclusion criteria and signing the informed consent could they be enrolled in the group to receive BTPNA to sample the target lesions The primary endpoint is the diagnostic yield of BTPNA The secondary endpoints include the success rate of navigation the operation time of the bronchoscope and so on
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None