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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Indiana University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01768325
First received: January 9, 2013
Last updated: November 6, 2013
Last verified: January 2010
  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.

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: January 2014 (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
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: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
ProCore Needle

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

ClinicalTrials.gov processed this record on April 17, 2014