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NCT04186390 Clinical Trial

Learning Small Bowel Capsule Endoscopy

Education Clinical Trial

Official title:
Learning Small Bowel Capsule Endoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04186390
Other study ID # OP_736
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 29, 2018
Est. completion date February 1, 2020

Study information
Verified date May 2022
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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%

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Medical Doctors in medical gastroenterology or surgery Exclusion Criteria: - Prior experience with evaluation of small bowel capsule endoscopy.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Odense University Hospital Odense Region Of Southern Denmark

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic sensitivity >90% Percentage of total number of correct diagnostic evaluated cases 1.5 year
Secondary Diagnostics Percentage of correct diagnostic description 1.5 year
Secondary Clinical consequence Percentage of correct clinical consequence 1.5 year
Secondary Total time Total time use for all evaluated cases. 1.5 year
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