Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02739126
Status:
UNKNOWN
Last Update Posted:
2016-04-15
First Post:
2016-02-19
Brief Title:
Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick 17mm Vs Thin 14 mm USS Probe
Sponsor:
Middlemore Hospital New Zealand
Organization:
Middlemore Hospital New Zealand
Study Overview
Official Title:
Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound Guided Biopsy When Using a Thick 17mm With an Aspiration Needle Biopsy Vs a Thin USS Probe 14mm in Peripheral Lung Lesions
Status:
UNKNOWN
Status Verified Date:
2016-04
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:
R-EBUST2
Brief Summary:
Obtaining a tissue sample to diagnose parenchymal lung lesions PPL suspected of cancerous origin is of utmost importance Due to its markedly favourable safety profile a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular However a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73 which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL 90 success rate is sub-optimal
There are 2 types of USS probes used in the R-EBUS procedure Whilst the thicker USS probe 17mm is capable of accommodating larger biopsy instruments the thinner USS probe could be advanced more peripherally to obtain a biopsy
Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield
In this study investigators compare these two types of probes in the ability to diagnose a PPL
The biopsy instruments used for both arms are forceps and cytology brush For the thick USS arm in addition an aspiration needle will also be used The thin USS guide sheath is too small to accommodate an aspiration needle
There are 2 types of USS probes used in the R-EBUS procedure Whilst the thicker USS probe 17mm is capable of accommodating larger biopsy instruments the thinner USS probe could be advanced more peripherally to obtain a biopsy
Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield
In this study investigators compare these two types of probes in the ability to diagnose a PPL
The biopsy instruments used for both arms are forceps and cytology brush For the thick USS arm in addition an aspiration needle will also be used The thin USS guide sheath is too small to accommodate an aspiration needle
Detailed Description:
None
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