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

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Duke University

Status

Withdrawn

Conditions

GI Lesions

Treatments

Device: Pro Core Needle
Device: medtronic Sharkcore Needle

Study type

Interventional

Funder types

Other

Identifiers

NCT03011229
Pro00077315

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Pro Core
Active Comparator group
Description:
Subject is randomized to ProCore standard needle.
Treatment:
Device: Pro Core Needle
Medtronic Shark Core
Experimental group
Description:
Subject is randomized to Medtronic Sharkcore needle
Treatment:
Device: medtronic Sharkcore Needle

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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