NCT04186390

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%

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

December 2, 2019

Last Update Submit

May 30, 2022

Conditions

EndoscopyEducationSimulationSmall Bowel DiseaseSmall Bowel Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic sensitivity >90%

    Percentage of total number of correct diagnostic evaluated cases

    1.5 year

Secondary Outcomes (3)

  • Diagnostics

    1.5 year

  • Clinical consequence

    1.5 year

  • Total time

    1.5 year

Study Arms (1)

Medical doctors

Medical doctors with no prior experience in the evaluation of small bowel capsule endoscopy.

Other: Simulation training in small bowel capsule endoscopy

Interventions

Simulation training in small bowel capsule endoscopyOTHER

Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.

Medical doctors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical Doctors in medical gastroenterology or surgery with no prior experience in the evaluation of small bowel capsule endoscopies.

You may qualify if:

  • Medical Doctors in medical gastroenterology or surgery

You may not qualify if:

  • Prior experience with evaluation of small bowel capsule endoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 4, 2019

Study Start

October 29, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

DK(1)