Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03621852|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment|
|Tumors of the Pancreas Submucosal Tumor of Gastrointestinal Tract (Disorder) Lymph Node Disease||Device: Endoultrasound guided FNB|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®) in Tumors of the Pancreas, Submucosal Tumors and Lymph Node Disease of the Upper GI Tract|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2020|
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.
Device: Endoultrasound guided FNB
EUS FNB with Aquire TM device
Other Name: EUS FNB with Aquire TM device
- tissue yield [ Time Frame: 12 month after FNB ]The primary outcome of the present study is to analyze the percentage in which a representative histological sample can be obtained by EUS-FNB (quality score 3 as defined by Payne et al.).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621852
|Contact: Ulrike Denzer, PD. Dr. email@example.com|
|Contact: Alexander Waldthaler, Dr.firstname.lastname@example.org|
|Universitätskliniken Gießen und Marburg, Standort Marburg||Recruiting|
|Marburg, Hessen, Germany, 35043|
|Contact: Ulrike Denzer, PD.Dr.med. 004964215866460 email@example.com|
|Principal Investigator: Ulrike Denzer, PD. Dr. med.|