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

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ClinicalTrials.gov Identifier: NCT01382680
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Other Specified Diseases of Biliary Tract Device: Guidewire

Detailed Description:
This is a randomized, monocentric study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : October 2010
Primary Completion Date : October 2013
Study Completion Date : October 2013
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Number of guidewires per ERCP session [ Time Frame: Within the same ERCP session (day 1) ]

Secondary Outcome Measures :
  1. Treatment aim [ Time Frame: day 1 ]
    Comparison of number of patients in whom the treatment aim could be achieved in both study groups

  2. Time of ERCP session [ Time Frame: day 1 ]
    Comparison of time needed for the ERCP session in both study groups.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382680


Locations
Germany
Department of Internal Medicine I
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Jörg G Albert, MD Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jorg Albert, Johann Wolfgang Goethe-University Hospitals, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01382680     History of Changes
Other Study ID Numbers: 136/10
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013