NCT01774513

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

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

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

January 22, 2013

Last Update Submit

January 22, 2013

Conditions

Autoimmune Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • diagnostic yield

    Number of patients with adequate tissue sample (which allows definitive diagnosis)

    6 months

Study Arms (1)

Procore Needle

EXPERIMENTAL
Device: Procore-Needle

Interventions

Procore-NeedleDEVICE
Procore Needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Autoimmune Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatitis, ChronicPancreatitisPancreatic DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stefan von Delius, MD

CONTACT

stefan_ruckert@yahoo.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

DE(1)