Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

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
Sponsor:
Information provided by (Responsible Party):
Ulrike Denzer, Philipps University Marburg Medical Center

Brief Summary:
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..

Condition or disease Intervention/treatment
Tumors of the Pancreas Submucosal Tumor of Gastrointestinal Tract (Disorder) Lymph Node Disease Device: Endoultrasound guided FNB

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ulrike Denzer, PD. Dr. med. 004964215866460 uwdenzer@gmail.com
Contact: Alexander Waldthaler, Dr.med. 004964215866460 alexanderwaldthaler@gmail.com

Locations
Layout table for location information
Germany
Universitätskliniken Gießen und Marburg, Standort Marburg Recruiting
Marburg, Hessen, Germany, 35043
Contact: Ulrike Denzer, PD.Dr.med.    004964215866460    uwdenzer@gmail.com   
Principal Investigator: Ulrike Denzer, PD. Dr. med.         
Sponsors and Collaborators
Philipps University Marburg Medical Center

Layout table for additonal information
Responsible Party: Ulrike Denzer, Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03621852     History of Changes
Other Study ID Numbers: VERSION 2 04/2017
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ulrike Denzer, Philipps University Marburg Medical Center:
Endosonography
fine needle biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Pancrelipase
Gastrointestinal Agents