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

Not Applicable

Withdrawn

• Conditions: GI Lesions

• Registration Number: NCT03011229
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Study Start: 2017-09-05
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of biopsy needle	end of biopsy, approximately 10 minutes

Trial Locations

Locations (1)

Duke; 🇺🇸 Durham, North Carolina, United States