Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692038
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2020-12-29
Brief Title:
Evaluate the Diagnostic Value of Puncture Biopsy for PPL Under the Guidance of Navigation and Radial EBUS a Real-World Study
Sponsor:
Guangzhou Institute of Respiratory Disease
Organization:
Guangzhou Institute of Respiratory Disease
Study Overview
Official Title:
A Real-World Study to Evaluate the Diagnostic Value of Puncture Biopsy for Peripheral Lung Nodules Under the Guidance of Augmented Reality Navigation System Combined With Radial EBUS
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_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:
The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound r-EBUS and to explore the factors influencing the diagnosis rate
Detailed Description:
The study will last for no longer than 12 months Patients will be first screened and only after meeting all the inclusion criteria not meeting any exclusion criteria and signing the informed consent could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy The secondary endpoints include the success rate of biopsy the operation time of the bronchoscope and so on
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