Short Versus Long Wire ERCP Systems

NCT ID: NCT00867204

Last Updated: 2011-09-20

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

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-01-31

Brief Summary

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This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.

Detailed Description

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Conditions

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Endoscopic Retrograde Cholangiopancreatography

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Short-wire device

The Fusion Short-wire ERCP device was used

ERCP

Intervention Type PROCEDURE

Patients with clinical indication for ERCP were invited to participate in the Study

Long-wire device

The traditional Long-wire ERCP device was used

ERCP

Intervention Type PROCEDURE

Patients with clinical indication for ERCP were invited to participate in the Study

Interventions

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ERCP

Patients with clinical indication for ERCP were invited to participate in the Study

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing ERCP.

Exclusion Criteria

* Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter V Draganov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida/Shands UF Endoscopy Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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ERCP systems

Identifier Type: -

Identifier Source: org_study_id

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