EndoscopyNCT04186390
Learning Small Bowel Capsule Endoscopy
An observational study of Endoscopy and Education, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity >90% Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endoscopy, Education, Simulation
- What is being tested?
- Simulation training in small bowel capsule endoscopy
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Oct 2018to 1 Feb 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: Medical Doctors in medical gastroenterology or surgery with no prior experience in the evaluation of small bowel capsule endoscopies.
Who may be able to join
- Medical Doctors in medical gastroenterology or surgery
Who cannot join
- Prior experience with evaluation of small bowel capsule endoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity >90%
- Being tested
- Simulation training in small bowel capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation training in small bowel capsule endoscopyOther
Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.
| Study group | Role | What they receive |
|---|---|---|
| Medical doctors | Medical doctors with no prior experience in the evaluation of small bowel capsule endoscopy. Receives: Other: Simulation training in small bowel capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity >90%
Percentage of total number of correct diagnostic evaluated cases
Measured: 1.5 year
Secondary outcomes (3)
Diagnostics
Percentage of correct diagnostic description
Measured: 1.5 year
Clinical consequence
Percentage of correct clinical consequence
Measured: 1.5 year
Total time
Total time use for all evaluated cases.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start29 Oct 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 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
- 20 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
- NCT04186390
- Sponsor's protocol ID
- OP_736
- Status last verified
- May 2022
- First submitted
- 2 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
- Learning Small Bowel Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT04186390
- Acronym / sponsor ID
- OP_736
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 Dec 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.
This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity >90%
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical doctors | – | Other: Simulation training in small bowel capsule endoscopyMedical doctors with no prior experience in the evaluation of small bowel capsule endoscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical Doctors in medical gastroenterology or surgery with no prior experience in the evaluation of small bowel capsule endoscopies.
Key inclusion criteria (1 listed)
- Medical Doctors in medical gastroenterology or surgery
Key exclusion criteria (1 listed)
- Prior experience with evaluation of small bowel capsule endoscopy.
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 small bowel capsule endoscopyTraining in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases. | Other | Medical doctors |
Primary outcome
Diagnostic sensitivity >90%
Time frame: 1.5 year
Percentage of total number of correct diagnostic evaluated cases
3 secondary outcomes
Diagnostics
Time frame: 1.5 year
Clinical consequence
Time frame: 1.5 year
Total time
Time frame: 1.5 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
Related trials for Endoscopy
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Recruiting
Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy
Patients Undergoing Gastrointestinal Endoscopy
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
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 Education, 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 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?
Diagnostic sensitivity >90% (time frame: 1.5 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.