Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)

NCT ID: NCT03621852

Last Updated: 2018-08-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-07-01

Brief Summary

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The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..

Detailed Description

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The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation.

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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Tumors of the Pancreas Submucosal Tumor of Gastrointestinal Tract (Disorder) Lymph Node Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

EUS FNB with Aquire TM device

Interventions

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Endoultrasound guided FNB

EUS FNB with Aquire TM device

Intervention Type DEVICE

Other Intervention Names

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EUS FNB with Aquire TM device

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Indication for EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included

Exclusion Criteria

* Cystic pancreatic tumors
* Contraindication for EUS FNB
* Lesion of interest cannot be reached endosonographically
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Ulrike Denzer

Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätskliniken Gießen und Marburg, Standort Marburg

Marburg, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrike Denzer, PD. Dr. med.

Role: CONTACT

004964215866460

Alexander Waldthaler, Dr.med.

Role: CONTACT

004964215866460

Facility Contacts

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Ulrike Denzer, PD.Dr.med.

Role: primary

004964215866460

Other Identifiers

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VERSION 2 04/2017

Identifier Type: -

Identifier Source: org_study_id

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