NCT00867204

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
Last Updated

September 20, 2011

Status Verified

March 1, 2009

Enrollment Period

3.3 years

First QC Date

March 19, 2009

Last Update Submit

September 16, 2011

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCPStudy focus was to compare the performance of the ERCP short-wire device versus the Long-wire device.

Outcome Measures

Primary Outcomes (1)

  • Time for device exchange and stent insertion

    during the ERCP

Study Arms (2)

Short-wire device

The Fusion Short-wire ERCP device was used

Procedure: ERCP

Long-wire device

The traditional Long-wire ERCP device was used

Procedure: ERCP

Interventions

ERCPPROCEDURE

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

Long-wire deviceShort-wire device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the clinical indication for an ERCP.

You may qualify if:

  • All patients undergoing ERCP.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida/Shands UF Endoscopy Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Peter V Draganov, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 23, 2009

Study Start

October 1, 2004

Primary Completion

February 1, 2008

Study Completion

January 1, 2009

Last Updated

September 20, 2011

Record last verified: 2009-03

Locations

US(1)