NCT01382680

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, monocentric study.

Conditions

• Other Specified Diseases of Biliary Tract

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-06-27
• Last updated: 2013-12-17

Locations

1 site across 1 country: Germany