Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)
NCT ID: NCT03621852
Last Updated: 2018-08-09
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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UNKNOWN
40 participants
OBSERVATIONAL
2017-07-01
2020-07-01
Brief Summary
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Detailed Description
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The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endoultrasound guided FNB
Patients with tumors of the pancreas, submucosal tumors or lymphnode disease of the upper gastrointestinal tract, which have to undergo EUS guided FNB.
Endoultrasound guided FNB
EUS FNB with Aquire TM device
Interventions
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Endoultrasound guided FNB
EUS FNB with Aquire TM device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication for EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included
Exclusion Criteria
* Contraindication for EUS FNB
* Lesion of interest cannot be reached endosonographically
18 Years
85 Years
ALL
No
Sponsors
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Philipps University Marburg
OTHER
Responsible Party
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Ulrike Denzer
Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy
Locations
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Universitätskliniken Gießen und Marburg, Standort Marburg
Marburg, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VERSION 2 04/2017
Identifier Type: -
Identifier Source: org_study_id
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