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

NCT ID: NCT01382680

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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This is a randomized, monocentric study.

Conditions

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Other Specified Diseases of Biliary Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Classic guidewires

Conventional guidewires used in combination as preferred by the investigating ERCP specialist

Group Type ACTIVE_COMPARATOR

Guidewire

Intervention Type DEVICE

Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)

New guidewire (G240)

Primary use of the new guidewire (G240)

Group Type ACTIVE_COMPARATOR

Guidewire

Intervention Type DEVICE

Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jorg Albert

Johann Wolfgang Goethe-University Hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jörg G Albert, MD

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I

Locations

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Department of Internal Medicine I

Frankfurt, , Germany

Site Status

Countries

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Germany

References

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Albert JG, Lucas K, Filmann N, Herrmann E, Schroder O, Sarrazin C, Trojan J, Kronenberger B, Bojunga J, Zeuzem S, Friedrich-Rust M. A novel, stiff-shaft, flexible-tip guidewire for cannulation of biliary stricture during endoscopic retrograde cholangiopancreatography: a randomized trial. Endoscopy. 2014 Oct;46(10):857-61. doi: 10.1055/s-0034-1377628. Epub 2014 Sep 10.

Reference Type DERIVED
PMID: 25208030 (View on PubMed)

Other Identifiers

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136/10

Identifier Type: -

Identifier Source: org_study_id