Viewing Study NCT02043327


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Study NCT ID: NCT02043327
Status: COMPLETED
Last Update Posted: 2014-01-23
First Post: 2014-01-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Simulation Based Training in Colonoscopy
Sponsor: Rigshospitalet, Denmark
Organization:

Study Overview

Official Title: Simulation-based Training for Colonoscopy: Establishing Criteria for Competency
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models

1. virtual reality simulator
2. physical model simulator To create pass/ fail standards for certification
Detailed Description: Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.

Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: