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

Not Applicable

Withdrawn

• Conditions: GI Lesions
• Interventions: Device: Pro Core Needle; Device: medtronic Sharkcore Needle

• 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• Status: WITHDRAWN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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pro Core	Pro Core Needle	Subject is randomized to ProCore standard needle.
Medtronic Shark Core	medtronic Sharkcore Needle	Subject is randomized to Medtronic Sharkcore needle

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