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

GI Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03011229
• Other study ID #: Pro00077315
• Status: Withdrawn
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: September 2019

Study information

• Verified date: May 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GI Lesions

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of biopsy needle		end of biopsy, approximately 10 minutes