Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)

Not Applicable

Completed

• Conditions: GIST
• Interventions: Device: EUS-Guided biopsy needle (ProCore); Device: EUS-TCB needle (QuickCore) standard of care

• Registration Number: NCT01768325
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.

This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.

Detailed Description

Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)

Secondary Objective To compare

* The number of needle passes requiring to acquire adequate specimen

* Length of core tissue obtained

* Diagnostic contribution of immunohistochemical staining

* Rates of complications

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-15
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Results First Submitted: 2015-07-23
• Results First Submitted QC: 2015-11-11
• Results First Posted: 2015-12-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-Guided biopsy needle (ProCore)	EUS-Guided biopsy needle (ProCore)	Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle. * The number of needle passes requiring to acquire adequate specimen * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications
EUS-TCB needle (Quick-Core)	EUS-TCB needle (QuickCore) standard of care	Comparison of core biopsy needles. * The number of needle passes requiring to acquire adequate specimen * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy.	36 months

Secondary Outcome Measures

Name	Time	Method
Number of Needle Passes	36 months
Overall Specimen Length	36 months

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States