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

NCT01768325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-03-29

Study results available
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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.

Conditions

Interventions

DEVICE

EUS-TCB needle (QuickCore) standard of care

* 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

DEVICE

EUS-Guided biopsy needle (ProCore)

* 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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • John M. DeWitt, M.D. · Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01768325 on ClinicalTrials.gov