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NCT00867204 Clinical Trial

Short Versus Long Wire ERCP Systems

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

— ERCP systems  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00867204
Other study ID # ERCP systems
Secondary ID
Status Completed
Phase N/A
First received March 19, 2009
Last updated September 16, 2011
Start date October 2004
Est. completion date January 2009

Study information
Verified date March 2009
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date January 2009
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Endoscopic Retrograde Cholangiopancreatography

Intervention

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

Locations
Country Name City State
United States University of Florida/Shands UF Endoscopy Center Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time for device exchange and stent insertion during the ERCP No
See also
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