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Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle

NCT02872831 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-13

No results posted yet for this study

Summary

The primary objective of this proposed prospective randomized, multi-center study is to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in the pancreas and gastrointestinal tract. The secondary objective is to determine the ability of the 22G SharkCore™ needle system to yield histologic tissue.

Conditions

Interventions

DEVICE

22G SharkCore™ needle

The 2 dedicated passes from the SharkCore™ needle will be placed in a jar with formaldehyde-based fixative and sent for routine histopathology evaluation. The cassette will be processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist, who was blinded to the randomization sequence, for the presence of a histologic tissue. If adequate histologic tissue is present, the specimen will be graded as optimal or suboptimal.

DEVICE

22G BNX EUS-FNA Needle

Aspirates will be placed onto glass slides and preserved with Diff-Quik stain (American Scientific Products, McGraw Park, Illinois, USA). In addition, a smear will also be placed in alcohol for Papanicolaou staining. Any additional material was sprayed into Hanks's solution and sent for cell block processing. The cytology technician or cytopathologist on site will verify adequacy of specimens. At least two passes will be obtained from the lesion unless the technician established the presence of malignant appearing cells.

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Ali Siddiqui, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02872831 on ClinicalTrials.gov