Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)
1 other identifier
interventional
85
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 15, 2015
CompletedMarch 29, 2017
February 1, 2017
2.3 years
January 9, 2013
July 23, 2015
February 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic Accuracy.
36 months
Secondary Outcomes (2)
Overall Specimen Length
36 months
Number of Needle Passes
36 months
Study Arms (2)
EUS-Guided biopsy needle (ProCore)
ACTIVE COMPARATORComparison 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-TCB needle (Quick-Core)
ACTIVE COMPARATORComparison 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
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- Solid tumors ≥ 2 cm in size.
You may not qualify if:
- Thrombocytopenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University Hospital
Indianapolis, Indiana, 46202-5121, United States
Results Point of Contact
- Title
- John DeWitt, MD
- Organization
- Indiana University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
John M. DeWitt, M.D.
Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 15, 2013
Study Start
January 1, 2012
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
March 29, 2017
Results First Posted
December 15, 2015
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share