CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
EUS-TCB needle (QuickCore) standard of care +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01768325
NCT01768325N/ACompleted
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Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.

Indiana University·interventional·Posted Jan 15, 2013·Updated Mar 29, 2017

In Brief

A clinical study evaluating EUS-TCB needle (QuickCore) standard of care and EUS-Guided biopsy needle (ProCore) for GIST. Completed, enrolled 85 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGIST
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartJan 1, 2012
Primary CompletionMay 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.5 years ago

Interventions

EUS-TCB needle (QuickCore) standard of caredevice

* The number of needle passes requiring to acquire adequate specimen were tallied. * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications

EUS-Guided biopsy needle (ProCore)device

* The number of needle passes requiring to acquire adequate specimen were tallied. * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications