Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)
This study is currently recruiting participants.
Verified January 2013 by Indiana University
Sponsor:
Indiana University
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01768325
First received: January 9, 2013
Last updated: January 14, 2013
Last verified: January 2013
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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 comparison to obtain diagnostic yield. Device: Core biopsy needle comparison to obtain diagnostic yield. |
| 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 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Core Biopsy Needle Comparison
Comparison of ProCore core biopsy needle to CuickCore core biopsy needle.
|
Device: Cook Medical core biopsy needle comparison to obtain diagnostic yield.
Other Name: Cook Medical ProCore biopsy needle compared to Cook Medical QuickCore biopsy needle in obtaining adequate specimen yield.
Device: Core biopsy needle comparison to obtain diagnostic yield.
Other Name: Core biopsy needle comparison to obtain diagnostic yield.
|
|
Active Comparator: Comparison of core biopsy needles
Te establish superiority in core biopsy yield comparing 2 similar core biopsy needles.
|
Device: Cook Medical core biopsy needle comparison to obtain diagnostic yield.
Other Name: Cook Medical ProCore biopsy needle compared to Cook Medical QuickCore biopsy needle in obtaining adequate specimen yield.
Device: Core biopsy needle comparison to obtain diagnostic yield.
Other Name: Core biopsy needle comparison to obtain diagnostic yield.
|
|
Active Comparator: ProCore needle
Core biopsy needle comparison to obtain diagnostic yield.
|
Device: Cook Medical core biopsy needle comparison to obtain diagnostic yield.
Other Name: Cook Medical ProCore biopsy needle compared to Cook Medical QuickCore biopsy needle in obtaining adequate specimen yield.
Device: Core biopsy needle comparison to obtain diagnostic yield.
Other Name: Core biopsy needle comparison to obtain diagnostic yield.
|
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: | January 14, 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 May 19, 2013