Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-29 @ 11:33 AM
Study NCT ID:
NCT01895166
Status:
UNKNOWN
Last Update Posted:
2013-07-31
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs
Sponsor:
Shanghai Chest Hospital
Organization:
Study Overview
Official Title:
Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2013-07
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:
The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.
Detailed Description:
The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).
Study Oversight
Has Oversight DMC:
True
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?: