N/A N=78 Randomized Single-blind Diagnostic

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

GIST

Bottom Line

View on ClinicalTrials.gov: NCT01768325 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: Diagnostic Accuracy. — 88; 62 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EUS-TCB needle (QuickCore) standard of care (Device); EUS-Guided biopsy needle (ProCore) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Diagnostic Accuracy.	88; 62	—
SECONDARY Overall Specimen Length	19.4; 4.3	—
SECONDARY Number of Needle Passes	2.07; 2.14	—

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.

Eligibility Criteria

Inclusion criteria

Solid tumors ≥ 2 cm in size.

Exclusion criteria

Thrombocytopenia

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Data sourced from ClinicalTrials.gov (NCT01768325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.