Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-30 @ 2:57 PM
Study NCT ID:
NCT01467635
Status:
WITHDRAWN
Last Update Posted:
2016-07-13
First Post:
2011-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EBUS-TBNA Versus EBUS-TBNB
Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Organization:
Study Overview
Official Title:
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
Status:
WITHDRAWN
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Manufacturer did not develop and deliver the necessary biopsy forceps needles in time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: