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

Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study

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.

Study Overview

• Status: Withdrawn
• Conditions: GI Lesions
• Intervention / Treatment: Device: Pro Core Needle; Device: medtronic Sharkcore Needle

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients age 18 or older referred for EUS found to have a hypoechoic lesion > 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS.
• Women that have a negative pregnant test

Exclusion Criteria:

• Patients under the age of 18.
• Uncorrectable coagulopathy (INR>1.5)
• Uncorrectable thrombocytopenia (platelet count <50,000)
• Patient who is unable to comply with study requirements
• Pregnant women
• Female patients who are not tested per our current unit protocol
• Refusal to consent or unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pro Core; Subject is randomized to ProCore standard needle.	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.
Experimental: Medtronic Shark Core; Subject is randomized to Medtronic Sharkcore needle	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
diagnostic accuracy of biopsy needle	end of biopsy, approximately 10 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Joshua Spaete, Duke Health System

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00077315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No