Comparison of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil and a Nitinol Guide Wire

December 16, 2013 updated by: Jorg Albert, Johann Wolfgang Goethe University Hospital

Comparison of the Use of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil Guide Wire With a Nitinol Wire in Patients With Stenosis of the Bile Ducts in ERCP

In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, monocentric study.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Department of Internal Medicine I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data)

Exclusion Criteria:

  • Operatively alternated anatomy of the patient.
  • Intervention of the pancreatic duct.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Classic guidewires
Conventional guidewires used in combination as preferred by the investigating ERCP specialist
Device: Guidewire
Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)
Other Names:
  • Terumo; RF-GA25263M, RF-GS25263M, RF-GS32403M, RF-PS25453M
  • G-240 2527S/A, G-240 2545S/A, G-240 3527S/A, G-240 545S/A
ACTIVE_COMPARATOR: New guidewire (G240)
Primary use of the new guidewire (G240)
Device: Guidewire
Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)
Other Names:
  • Terumo; RF-GA25263M, RF-GS25263M, RF-GS32403M, RF-PS25453M
  • G-240 2527S/A, G-240 2545S/A, G-240 3527S/A, G-240 545S/A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of guidewires per ERCP session
Time Frame: Within the same ERCP session (day 1)
Within the same ERCP session (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment aim
Time Frame: day 1
Comparison of number of patients in whom the treatment aim could be achieved in both study groups
day 1
Time of ERCP session
Time Frame: day 1
Comparison of time needed for the ERCP session in both study groups.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Jörg G Albert, MD, Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 136/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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