NCT03621852

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..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

July 24, 2018

Last Update Submit

August 8, 2018

Conditions

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

Keywords

Endosonographyfine needle biopsy

Outcome Measures

Primary Outcomes (1)

  • tissue yield

    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.).

    12 month after FNB

Study Arms (1)

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

Interventions

Endoultrasound guided FNBDEVICE

EUS FNB with Aquire TM device

Also known as: EUS FNB with Aquire TM device
Endoultrasound guided FNB

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract.

You may qualify if:

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

You may not qualify if:

  • Cystic pancreatic tumors
  • Contraindication for EUS FNB
  • Lesion of interest cannot be reached endosonographically

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätskliniken Gießen und Marburg, Standort Marburg

Marburg, Hesse, 35043, Germany

RECRUITING

Central Study Contacts

Ulrike Denzer, PD. Dr. med.

CONTACT

004964215866460uwdenzer@gmail.com

Alexander Waldthaler, Dr.med.

CONTACT

004964215866460alexanderwaldthaler@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 9, 2018

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)