Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT04032951
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination
Sponsor:
Catholic University of the Sacred Heart
Organization:
Study Overview
Official Title:
Evaluation of a Newly Designed 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination in Patients With Solid Lesions: A Prospective Two Centers Study
Status:
COMPLETED
Status Verified Date:
2019-07
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:
EUSFNTA
Brief Summary:
To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.
Detailed Description:
The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.
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?: