PainendosimNCT00576043
Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy
A study testing Simulator Training in people with Pain, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Simulator Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2004to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Trainees: naive to real patient endoscopy before training phase
Who cannot join
- Medical doctors with experience in gastrointestinal endoscopy
- Patients sedated for upper GI endoscopy
- Patients unwilling or unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site
Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna
Vienna, 1090
About this study
Official title: Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial
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.
- Conditions
- Pain
- Being tested
- Simulator Training
- Keywords
- training, Patient satisfaction, endoscopy, simulator, Safety
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator TrainingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 1: Training | Active comparator | 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator Receives: Procedure: Simulator Training |
| 2: No Training | No intervention | No simulator training before starting endoscopy training on real patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction measured on a visual analogue scale (VAS)
Measured: once immediately after patient endoscopy
Secondary outcomes (4)
pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)
Measured: once immediately after patient endoscopy
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)
Measured: during endoscopy
number of found/missed pathologies
Measured: during endoscopy
average time for successful endoscopy
Measured: during endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startMar 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Arnulf Ferlitsch, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576043
- Sponsor's protocol ID
- endosim
- Acronym
- endosim
- Status last verified
- Mar 2008
- First submitted
- 17 Dec 2007
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00576043
- Acronym / sponsor ID
- endosim / endosim
- Conditions
- Pain
- Keywords
- training, Patient satisfaction, endoscopy, simulator, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Training | Active comparator | Procedure: Simulator Training3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator |
| 2: No Training | No intervention | –No simulator training before starting endoscopy training on real patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Trainees: naive to real patient endoscopy before training phase
Key exclusion criteria (3 listed)
- Medical doctors with experience in gastrointestinal endoscopy
- Patients sedated for upper GI endoscopy
- Patients unwilling or unable to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulator Training3 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 | Procedure or surgery | 1: Training |
Primary outcome
Patient satisfaction measured on a visual analogue scale (VAS)
Time frame: once immediately after patient endoscopy
4 secondary outcomes
pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)
Time frame: once immediately after patient endoscopy
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
number of found/missed pathologies
Time frame: during endoscopy
average time for successful endoscopy
Time frame: during endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
- Background: PubMed 12195326Ferlitsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnulf Ferlitsch, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulator Training in people with Pain, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction measured on a visual analogue scale (VAS) (time frame: once immediately after patient endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2008.