EndoscopyNCT04247399
Simulation-assisted Teaching in Learning Gastroscopy
A study testing Simulation-based learning in people with Endoscopy and Education, run by Anders Bo Nielsen at 1 site in Denmark.
Trial summary
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Education, Gastroscopy
- What is being tested?
- Simulation-based learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2020to 1 May 2022
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical doctors in medical gastroenterology or surgery
Who cannot join
- prior experience with gastroscopy
Trial locations and contacts
1 site in 1 country.
About this study
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.
- Conditions
- Endoscopy, Education, Gastroscopy, Esophagogastroduodenoscopy, Simulation
- Being tested
- Simulation-based learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based learningOther
Pre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-based learning + clinical training | Experimental | Not described Receives: Other: Simulation-based learning |
| Clinical training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedures before declared unassisted
Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies
Measured: 1 year
Secondary outcomes (5)
Patient satisfaction
Survey using "Gastrointestinal Endoscopy Satisfaction Questionnaire" a validated questionnaire using a scale from 1-5 (5 is the best).
Measured: 1 year
Complication rate
Measured: 1 year
Mucosa visualization percent of the upper gastrointestinal tract
Assessed by endoscopy experts at video documented endoscopies
Measured: 1 year
Duration of intubation
Duration of time that the patient is intubated with the endoscope
Measured: 1 year
Time
Total time for the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start15 Feb 2020
- Primary completion30 Jan 2022
- Study completion1 May 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Bo Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Bo Nielsen, Odense University Hospital
- Investigators
- Anders Bo Nielsen, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247399
- Sponsor's protocol ID
- OP_972
- Status last verified
- May 2022
- First submitted
- 19 Dec 2019
- Last updated
- 1 Jun 2022
- 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-assisted Teaching in Learning Gastroscopy
- ClinicalTrials.gov ID
- NCT04247399
- Acronym / sponsor ID
- OP_972
- Conditions
- Endoscopy, Education, Gastroscopy, Esophagogastroduodenoscopy, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Anders Bo NielsenUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 30 Jan 2020 (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.
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation-based learning + clinical training | Experimental | Other: Simulation-based learning |
| Clinical training | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical doctors in medical gastroenterology or surgery
Key exclusion criteria (1 listed)
- prior experience with gastroscopy
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-based learningPre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom. | Other | Simulation-based learning + clinical training |
Primary outcome
Number of procedures before declared unassisted
Time frame: 1 year
Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies
5 secondary outcomes
Patient satisfaction
Time frame: 1 year
Complication rate
Time frame: 1 year
Mucosa visualization percent of the upper gastrointestinal tract
Time frame: 1 year
Duration of intubation
Time frame: 1 year
Time
Time frame: 1 year
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 Jun 2022.
- 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.
Anders Bo Nielsen, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based learning in people with Endoscopy and Education, run by Anders Bo Nielsen 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 1 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 Jun 2022. 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?
Number of procedures before declared unassisted (time frame: 1 year). 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 Jun 2022.