Prospective Evaluation of the Diagnostic Efficacy of a EU... | NCT03621852

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

NCT03621852

Sponsor

Philipps University Marburg

Status

Unknown status

Last Update Posted

Aug 9, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

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

Interventions

Endoultrasound guided FNB

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jul 1, 2019Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Aug 8, 2018

First Posted Date

Aug 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2018

Last Update Posted Date

Aug 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ulrike Denzer, Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy, Philipps University MarburgPrincipal Investigator

Lead Sponsor

Philipps University MarburgOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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..

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Endoultrasound guided FNB	Device	EUS FNB with Aquire TM device	Endoultrasound guided FNB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ulrike Denzer, PD. Dr. med.	Contact	004964215866460		uwdenzer@gmail.com
Alexander Waldthaler, Dr.med.	Contact	004964215866460		alexanderwaldthaler@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätskliniken Gießen und Marburg, Standort Marburg	Recruiting	Marburg	Hesse	35043	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided