Department of Internal Medicine I
Frankfurt, 60590, Germany
Completed
NCT Number: NCT01382680
Comparison of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil and a Nitinol Guide Wire
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This is a randomized, monocentric study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Guidewire
DeviceUse 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
Primary outcomes
-
Number of guidewires per ERCP session
Time frame: Within the same ERCP session (day 1)
Secondary outcomes
-
Treatment aim
Time frame: day 1
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
Comparison of time needed for the ERCP session in both study groups.
Sponsors and collaborators
Lead sponsor
Johann Wolfgang Goethe University Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2010
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jun 27, 2011
- Registry last updated
- Dec 17, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.