Comparison of Two High Performance Guidewires in ERCP

NACompletedINTERVENTIONAL
Enrollment

453

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

October 31, 2019

Study Completion Date

January 31, 2020

Conditions
Stenosis of Bile Duct
Interventions
DEVICE

VisiGlide™ angled tip

Arm A: Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner)

DEVICE

VisiGlide2™ angled tip

Arm B: Primary use of VisiGlide2™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (straight tip) resp. to VisiGlide™ (tip according to the examiner)

DEVICE

VisiGlide™ straight tip

Arm C: Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner)

DEVICE

VisiGlide2™ straight tip

Arm D: Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide1™ (tip according to the examiner)

Trial Locations (1)

60590

Goethe University Hospital Frankfurt, Frankfurt am Main

All Listed Sponsors
collaborator

Klinikum Stadt Hanau

OTHER

collaborator

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

OTHER

collaborator

Robert Bosch Medical Center

OTHER

lead

Johann Wolfgang Goethe University Hospital

OTHER

NCT03638700 - Comparison of Two High Performance Guidewires in ERCP | Biotech Hunter | Biotech Hunter