MedTrace Logo

Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule

NCT03011229 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-05-07

No results posted yet for this study

Summary

The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle.

The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.

Conditions

  • GI Lesions

Interventions

DEVICE

Pro Core Needle

Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.

DEVICE

medtronic Sharkcore Needle

Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.

Sponsors & Collaborators

Principal Investigators

  • Joshua Spaete · Duke Health System

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03011229 on ClinicalTrials.gov