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

Withdrawn before enrolling · Not applicable

Conditions studied: GI Lesions

In brief

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.

Key facts

Study ID

NCT03011229

Run by

Duke University

People needed

0

Starts

2017-09-05

Expected to finish

2019-09-01

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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