NCT01080833

Brief Summary

Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
Last Updated

March 19, 2010

Status Verified

March 1, 2010

Enrollment Period

11 months

First QC Date

March 1, 2010

Last Update Submit

March 18, 2010

Conditions

Training

Keywords

EMSERCPTrainingTrainees

Outcome Measures

Primary Outcomes (1)

  • Diagnostic biliary cannulation and deep biliary cannulation success rates

    The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation

    12 months

Secondary Outcomes (1)

  • Trainer assessment

    12 months

Study Arms (2)

ERCP mechanical simulator practice

ACTIVE COMPARATOR

Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)

Device: ERCP mechanical simulator practice

No ERCP mechanical simulator practice

NO INTERVENTION

Trainees undergoing routine ERCP training only (control group).

Interventions

ERCP mechanical simulator practiceDEVICE

Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training

ERCP mechanical simulator practice

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastrointestinal fellows receiving ERCP training

You may not qualify if:

  • Gastrointestinal fellows who are not receiving ERCP training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Leung JW, Lee JG, Rojany M, Wilson R, Leung FW. Development of a novel ERCP mechanical simulator. Gastrointest Endosc. 2007 Jun;65(7):1056-62. doi: 10.1016/j.gie.2006.11.018.

    PMID: 17531642BACKGROUND

Study Officials

  • Joseph W Leung, MD

    Sacramento VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 4, 2010

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

March 19, 2010

Record last verified: 2010-03

Locations

US(1)