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

February 28, 2017 updated by: Indiana University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5121
        • Indiana University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Solid tumors ≥ 2 cm in size.

Exclusion criteria:

  • Thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
Other Names:
  • Comparison of core biopsy needles.
Active Comparator: EUS-TCB needle (Quick-Core)

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
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
Other Names:
  • Comparison of core biopsy needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic Accuracy.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Specimen Length
Time Frame: 36 months
36 months
Number of Needle Passes
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1104-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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