GI Lesions
Conditions
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.
Interventions
DEVICEPro 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.
DEVICEmedtronic 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic accuracy of biopsy needle | end of biopsy, approximately 10 minutes |
Countries
United States
Outcome results
None listed