EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancre... | NCT01774513

Studies
EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

NCT01774513

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Jan 24, 2013Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Autoimmune Pancreatitis

Interventions

Procore-Needle

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

Jan 2013

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

Jan 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 22, 2013

First Submission Date that Met QC Criteria

Jan 22, 2013

First Posted Date

Jan 24, 2013Estimated

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

Jan 22, 2013

Last Update Posted Date

Jan 24, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Label	Type	Description	Intervention Names
Procore Needle	Experimental		Device: Procore-Needle

Name	Type	Description	Arm Group Labels	Other Names
Procore-Needle	Device		Procore Needle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic yield	Number of patients with adequate tissue sample (which allows definitive diagnosis)	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient age 18 years and older
patients with suspicion of autoimmune pancreatitis (based on the findings in EUS and MRI)

Exclusion Criteria:

unable to obtain informed consent
ASA class 4 and 5
known pregnancy
contraindication for endoscopy or for biopsy sampling
patients with high suspicion on pancreatic cancer (based on the findings in radiology and EUS)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan von Delius, MD	Contact			stefan_ruckert@yahoo.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar	Recruiting	Munich	Bavaria	81675	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000081012	Autoimmune Pancreatitis

Ancestor Terms

ID	Term
D050500	Pancreatitis, Chronic
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided