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

Gastrointestinal Tumors. Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768325
• Other study ID #: 1104-03
• Status: Completed
• Phase: N/A
• First received: January 9, 2013
• Last updated: November 11, 2015
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Solid tumors = 2 cm in size.

Exclusion criteria:

• Thrombocytopenia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Tumors.

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy.		36 months	No
Secondary	Overall Specimen Length		36 months	No
Secondary	Number of Needle Passes		36 months	No