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

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ClinicalTrials.gov Identifier: NCT01768325
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : December 15, 2015
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
GIST Device: EUS-TCB needle (QuickCore) standard of care Device: EUS-Guided biopsy needle (ProCore)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
Study Start Date : January 2012
Primary Completion Date : May 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Comparison of core biopsy needles.


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic Accuracy. [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Overall Specimen Length [ Time Frame: 36 months ]
  2. Number of Needle Passes [ Time Frame: 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Solid tumors ≥ 2 cm in size.

Exclusion criteria:

  • Thrombocytopenia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768325


Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202-5121
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: John M. DeWitt, M.D. Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121
More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01768325     History of Changes
Other Study ID Numbers: 1104-03
First Posted: January 15, 2013    Key Record Dates
Results First Posted: December 15, 2015
Last Update Posted: March 29, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Indiana University:
ProCore Needle