NCT01997177

Brief Summary

Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion analysis. In order to develop a non-biased tool to monitor competence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 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

March 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

November 22, 2013

Last Update Submit

November 22, 2013

Conditions

Sensitivity Training Groups

Keywords

simulationtrainingcolonoscopystandard setting

Outcome Measures

Primary Outcomes (1)

  • to identify metrics of importans in colonoscopy training program

    testing colonoscopy competence in a simulation lab. Finding metrics with discriminatory ability.

    3 months

Study Arms (2)

novices

novice endoscopists, fellows of gastroenterology

experienced endoscopist

consultant doctors of gastroenterology

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Doctors in gastroenterology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEKU, Centre of Clinical education

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Preisler L, Sondergaard Svendsen MB, Sondergaard B, Brink L, Nordentoft T, Svendsen LB, Konge L. Automatic and unbiased assessment of competence in colonoscopy: exploring validity of the Colonoscopy Progression Score (CoPS). Endosc Int Open. 2016 Dec;4(12):E1238-E1243. doi: 10.1055/s-0042-118226. Epub 2016 Nov 17.

    PMID: 27995182DERIVED

Study Officials

  • Louise Preisler, MD

    CEKU, Centre of clinical education, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 22, 2013

First Posted

November 27, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

DK(1)