NCT03011229
Withdrawn
Not Applicable
Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study
ConditionsGI Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- GI Lesions
- Sponsor
- Duke University
- Locations
- 1
- Primary Endpoint
- diagnostic accuracy of biopsy needle
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
diagnostic accuracy of biopsy needle
Time Frame: end of biopsy, approximately 10 minutes
Study Sites (1)
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