Learning Small Bowel Capsule Endoscopy | NCT04186390

Studies
Learning Small Bowel Capsule Endoscopy

NCT04186390

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Jun 1, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Endoscopy
Education
Simulation
Small Bowel Disease
Small Bowel Capsule Endoscopy

Interventions

Simulation training in small bowel capsule endoscopy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2018Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Dec 2, 2019

First Submission Date that Met QC Criteria

Dec 2, 2019

First Posted Date

Dec 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2022

Last Update Posted Date

Jun 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Simulation training in small bowel capsule endoscopy	Other	Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic sensitivity >90%	Percentage of total number of correct diagnostic evaluated cases	1.5 year

Secondary Outcomes

Measure	Description	Time Frame
Diagnostics	Percentage of correct diagnostic description	1.5 year
Clinical consequence	Percentage of correct clinical consequence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medical Doctors in medical gastroenterology or surgery

Exclusion Criteria:

Prior experience with evaluation of small bowel capsule endoscopy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense	Region Syddanmark	5000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided