Short Versus Long Wire ERCP Systems (ERCP systems)

September 16, 2011 updated by: University of Florida

Prospective Randomized Blinded Comparison of a Short-wire ERCP System to Traditional Long-wire Devices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida/Shands UF Endoscopy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with the clinical indication for an ERCP.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Short-wire device
The Fusion Short-wire ERCP device was used
Procedure: ERCP
Patients with clinical indication for ERCP were invited to participate in the Study
Long-wire device
The traditional Long-wire ERCP device was used
Procedure: ERCP
Patients with clinical indication for ERCP were invited to participate in the Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time for device exchange and stent insertion
Time Frame: during the ERCP
during the ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 20, 2009

First Posted (Estimate)

March 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 20, 2011

Last Update Submitted That Met QC Criteria

September 16, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERCP systems

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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