EndoscopyNCT04150237
Using Simulation to Ensure Basic Competence in Gastroscopy
An observational study of Endoscopy and Simulation, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endoscopy, Simulation, Education
- What is being tested?
- Simulation training in gastroscopy
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 1 Jan 2020
- Phase
- Observational
- 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
Study population: The medical students will be recruited after passing their anatomy exam at the University of Southern Denmark. The endoscopy nurses will be recruited at Odense University Hospital. Medical doctors in medical gastroenterology and surgery will be recruited at the Odense University Hospital, Denmark.
Who may be able to join
- Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam.
- Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies.
- Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.
- Conditions
- Endoscopy, Simulation, Education, Gastroscopy
- Being tested
- Simulation training in gastroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation training in gastroscopyOther
Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.
| Study group | Role | What they receive |
|---|---|---|
| Novices | Medical students Receives: Other: Simulation training in gastroscopy | |
| Intermediates | Endoscopy (EGD) assisting nurses. No prior self-performed endoscopies Receives: Other: Simulation training in gastroscopy | |
| Experienced | Medical doctors in medical Gastroenterology or surgery, who have self-performed more than 500 EGD Receives: Other: Simulation training in gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulation gastroscopy test score
Test score based on time usage, landmark and pathology recognition
Measured: 1-hour test
Secondary outcomes (3)
Total time for the diagnostic exercises
A total time for two diagnostic virtual reality tests and a test on a phantom
Measured: 1-hour test
Total time for the tool exercises
A total time of virtual reality tests and two tests on a phantom
Measured: 1-hour test
Total landmark and pathology recognition for the diagnostic exercises
Recognition of a total number of 48 landmarks and pathologies
Measured: 1-hour test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Oct 2019
- Primary completion30 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Bo Nielsen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150237
- Sponsor's protocol ID
- OP_971
- Status last verified
- Sep 2021
- First submitted
- 29 Oct 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Simulation to Ensure Basic Competence in Gastroscopy
- ClinicalTrials.gov ID
- NCT04150237
- Acronym / sponsor ID
- OP_971
- Conditions
- Endoscopy, Simulation, Education, Gastroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- 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.
The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novices | – | Other: Simulation training in gastroscopyMedical students |
| Intermediates | – | Other: Simulation training in gastroscopyEndoscopy (EGD) assisting nurses. No prior self-performed endoscopies |
| Experienced | – | Other: Simulation training in gastroscopyMedical doctors in medical Gastroenterology or surgery, who have self-performed more than 500 EGD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The medical students will be recruited after passing their anatomy exam at the University of Southern Denmark. The endoscopy nurses will be recruited at Odense University Hospital. Medical doctors in medical gastroenterology and surgery will be recruited at the Odense University Hospital, Denmark.
Key inclusion criteria (3 listed)
- Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam.
- Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies.
- Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Simulation training in gastroscopySimulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom. | Other | Experienced, Intermediates, Novices |
Primary outcome
Simulation gastroscopy test score
Time frame: 1-hour test
Test score based on time usage, landmark and pathology recognition
3 secondary outcomes
Total time for the diagnostic exercises
Time frame: 1-hour test
Total time for the tool exercises
Time frame: 1-hour test
Total landmark and pathology recognition for the diagnostic exercises
Time frame: 1-hour test
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 1 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy and Simulation, run by Odense University Hospital at 1 site in Denmark.
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 3 inclusion and 1 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 1 Oct 2021. 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 Denmark. 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?
Simulation gastroscopy test score (time frame: 1-hour test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2021.