Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)
NCT ID: NCT01768325
Last Updated: 2017-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2012-01-31
2014-08-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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
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
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
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Principal Investigators
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John M. DeWitt, M.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121
Locations
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Indiana University Hospital
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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1104-03
Identifier Type: -
Identifier Source: org_study_id
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