At a glance
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Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
In Brief
A clinical study evaluating cholangioscopy (Frimberger) for Choledocholithiasis and 2 related conditions. Completed, enrolled 59 participants across 5 sites.
Detailed Summary
Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic device, which is designed to give a better flexibility to the cholangioscopy tip in order to enable optimal diagnostic and therapeutic precondition. Other than the conventional mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at the side of a specially developed duodenoscope (mother part) which is prepositioned distally to the control unit, near to the patient's mouth. Better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres. This study is designed to test the efficiency of the device in relation to this assumption.
Study Details
Timeline
Interventions
cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH