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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01768325
First received: January 9, 2013
Last updated: June 16, 2016
Last verified: June 2016
  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: EUS-TCB needle (QuickCore) standard of care
Device: EUS-Guided biopsy needle (ProCore)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • Diagnostic Accuracy. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Specimen Length [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Number of Needle Passes [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: January 2012
Study Completion Date: August 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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   (Adult, Senior)
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

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 
Study First Received: January 9, 2013
Results First Received: July 23, 2015
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 July 21, 2016