Learning Small Bowel Capsule Endoscopy
Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04186390
Collaborator
(none)
20
1
15.1
1.3
Study Details
Study Description
Brief 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%
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Learning Small Bowel Capsule Endoscopy
Actual Study Start Date
:
Oct 29, 2018
Actual Primary Completion Date
:
Feb 1, 2020
Actual Study Completion Date
:
Feb 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Medical doctors Medical doctors with no prior experience in the evaluation of small bowel capsule endoscopy. |
Other: Simulation training in small bowel capsule endoscopy
Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.
|
Outcome Measures
Primary Outcome Measures
- Diagnostic sensitivity >90% [1.5 year]
Percentage of total number of correct diagnostic evaluated cases
Secondary Outcome Measures
- Diagnostics [1.5 year]
Percentage of correct diagnostic description
- Clinical consequence [1.5 year]
Percentage of correct clinical consequence
- Total time [1.5 year]
Total time use for all evaluated cases.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Medical Doctors in medical gastroenterology or surgery
Exclusion Criteria:
- Prior experience with evaluation of small bowel capsule endoscopy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Odense University Hospital | Odense | Region Of Southern Denmark | Denmark | 5000 |
Sponsors and Collaborators
- Odense University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anders Bo Nielsen,
Medical Doctor,
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT04186390
Other Study ID Numbers:
- OP_736
First Posted:
Dec 4, 2019
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: