Short Versus Long Wire ERCP Systems | NCT00867204

Studies
Short Versus Long Wire ERCP Systems

NCT00867204

Sponsor

University of Florida

Status

Completed

Last Update Posted

Sep 20, 2011Estimated

Enrollment

71Actual

Phase

Not provided

Conditions

Endoscopic Retrograde Cholangiopancreatography

Interventions

ERCP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Feb 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Mar 19, 2009

First Submission Date that Met QC Criteria

Mar 20, 2009

First Posted Date

Mar 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2011

Last Update Posted Date

Sep 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ERCP	Procedure	Patients with clinical indication for ERCP were invited to participate in the Study	Long-wire device Short-wire device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with the clinical indication for an ERCP.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter V Draganov, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida/Shands UF Endoscopy Center		Gainesville	Florida	32610	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002760	Cholangiopancreatography, Endoscopic Retrograde

Ancestor Terms

ID	Term
D002758	Cholangiography
D011860	Radiography, Abdominal
D011859	Radiography
D003952	Diagnostic Imaging

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Browse Branches

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