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CompletedNCT00576043endosimUpdated Mar 27, 2008

Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

An interventional study of Simulator Training in Pain, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Per ClinicalTrials.gov, last updated 2008-03-27.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Sex
All
01

Study summary

Trainees (Residents in internal medicine), naive to real patient endoscopy, will be randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction and pain, technical accuracy and number of found/missed pathologies as well as average time for successful endoscopy will be recorded. After one month or 50 supervised, self performed endoscopies, trainees will be evaluated again with the above mentioned criteria during ten consecutive investigations.

02

Conditions studied

  • Pain

Keywords

  • training
  • Patient satisfaction
  • endoscopy
  • simulator
  • Safety
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Trainees: naive to real patient endoscopy before training phase

Exclusion criteria

Exclusion Criteria:

  • Medical doctors with experience in gastrointestinal endoscopy
  • Patients sedated for upper GI endoscopy
  • Patients unwilling or unable to sign informed consent
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    1: Training

    3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator

    Procedure: Simulator Training

  • No intervention
    2: No Training

    No simulator training before starting endoscopy training on real patients

Interventions

  • ProcedureSimulator Training

    3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator with the GI-Mentor Virtual simulator device

06

What researchers measure

Primary outcomes

  1. Patient satisfaction measured on a visual analogue scale (VAS)

    Time frame: once immediately after patient endoscopy

Secondary outcomes

  1. pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)

    Time frame: once immediately after patient endoscopy

  2. technical accuracy (oral introduction of the scope into the esophagus, ability of passing the endoscope through the pylorus, inversion of the scope in the gastric fundus)

    Time frame: during endoscopy

  3. number of found/missed pathologies

    Time frame: during endoscopy

  4. average time for successful endoscopy

    Time frame: during endoscopy

07

Study locations

1 site
  • Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna
    Vienna, 1090, Austria
08

References and documents

Publications

  • Ferlitsch A, Glauninger P, Gupper A, Schillinger M, Haefner M, Gangl A, Schoefl R. Evaluation of a virtual endoscopy simulator for training in gastrointestinal endoscopy. Endoscopy. 2002 Sep;34(9):698-702. doi: 10.1055/s-2002-33456. PubMed 12195326 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00576043
Lead sponsor
Medical University of Vienna
First posted
Dec 18, 2007
Start date
Mar 2004
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Mar 27, 2008

Study contacts

Arnulf Ferlitsch, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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