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Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)

NCT02766842 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-05-15

No results posted yet for this study

Summary

Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.

Conditions

Interventions

PROCEDURE

EUS-FNB with ProCore needle

The use of the standard ProCore needle to acquire diagnostic tissue

PROCEDURE

EUS-FNB with SharkCore needle

The use of new SharkCore needle to acquire diagnostic tissue

DEVICE

ProCore needle

This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance

DEVICE

SharkCore needle

This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.

Sponsors & Collaborators

Principal Investigators

  • Mouen Khashab, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02766842 on ClinicalTrials.gov