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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01768325
First received: January 9, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention
Gastrointestinal Tumors.
Device: Cook Medical core biopsy needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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.

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The size of core biopsy obtained by the ProCore and QuickCore biopsy needles. Larger core iopsy specimen-yield. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 76
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Core Biopsy Needle Comparison
Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle
Device: Cook Medical core biopsy needle
Obtaining a larger specimen.
Other Name: Biopsy needle comparison to QuikCore needle.
Active Comparator: Comparison of core biopsy needles
Comparison of core biopsy needles.
Device: Cook Medical core biopsy needle
Obtaining a larger specimen.
Other Name: Biopsy needle comparison to QuikCore needle.
Active Comparator: ProCore needle
Core biopsy needle comparison to obtain diagnostic yield.
Device: Cook Medical core biopsy needle
Obtaining a larger specimen.
Other Name: Biopsy needle comparison to QuikCore needle.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Solid tumors ≥ 2 cm in size.

Exclusion criteria:

  • Thrombocytopenia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768325

Contacts
Contact: Kathleen A. McGreevy, R.N. 317-944-5392 kmcgreev@iupui.edu

Locations
United States, Indiana
Indiana University Hospital Recruiting
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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01768325     History of Changes
Other Study ID Numbers: 1104-03
Study First Received: January 9, 2013
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
ProCore Needle

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 27, 2014