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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorg Albert, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01382680
First received: June 22, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
Other Specified Diseases of Biliary Tract
Device: Guidewire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Number of guidewires per ERCP session [ Time Frame: Within the same ERCP session (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment aim [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Comparison of number of patients in whom the treatment aim could be achieved in both study groups

  • Time of ERCP session [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Comparison of time needed for the ERCP session in both study groups.


Enrollment: 222
Study Start Date: October 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This is a randomized, monocentric study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382680

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

No publications provided

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
Study First Received: June 22, 2011
Last Updated: December 16, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on November 25, 2014