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Completed

NCT Number: NCT01768325

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

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.

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Key information

Conditions

GIST

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Solid tumors ≥ 2 cm in size.

Exclusion criteria

  • Thrombocytopenia

Treatment and study plan

EUS-TCB needle (QuickCore) standard of care

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

Other names: Comparison of core biopsy needles.

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

Other names: Comparison of core biopsy needles.

Primary outcomes

  1. Diagnostic Accuracy.

    Time frame: 36 months

Secondary outcomes

  1. Overall Specimen Length

    Time frame: 36 months

  2. Number of Needle Passes

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 15, 2013
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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