Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule
NCT ID: NCT03011229
Last Updated: 2020-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-09-05
2019-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Pro Core
Subject is randomized to ProCore standard needle.
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 Shark Core
Subject is randomized to Medtronic Sharkcore needle
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Women that have a negative pregnant test
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Joshua Spaete
Role: PRINCIPAL_INVESTIGATOR
Duke Health System
Locations
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Duke
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00077315
Identifier Type: -
Identifier Source: org_study_id
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