- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05076188
PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS (PARADIS_1)
October 27, 2021 updated by: Poitiers University Hospital
This study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department.
This is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software.
All performances will be evaluated and compared.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Poitiers, France, 86000
- C.H.U. de Poitiers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Radiographer : a health practionner with official autorisation to use X-ray imagery.
Description
Inclusion Criteria:
- Working in an emergency radiography department Volunteer to participate in the study
Exclusion Criteria:
- Planned departure from the establishment within 12 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the radiographers' diagnostic performance to issue an advisory opinion to X-ray reading of the appendicular skeleton in emergency department
Time Frame: 2 hours
|
The primary outcome measure evaluation radiographers' diagnostic will use accurancy, sensibility and specificity.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantify the proportion of radiographers reaching the goal of 90% accurancy
Time Frame: 4 months
|
This is a proportion in % of performance radiographers' diagnosctic treshold
|
4 months
|
|
Quantify and qualify Radiographers diagnostic changes before and after the in house training.
Time Frame: 4 months
|
This a proportion in % about the progression of performance radiographers'diagnostic in the formation.
|
4 months
|
|
Evaluate the performance of the association of AI and radiographer after training
Time Frame: 4 months
|
Thiis output is the difference between accurancy, sensibility and sensitivity with or without IA.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
September 30, 2021
First Submitted That Met QC Criteria
September 30, 2021
First Posted (Actual)
October 13, 2021
Study Record Updates
Last Update Posted (Actual)
November 2, 2021
Last Update Submitted That Met QC Criteria
October 27, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Paradis_1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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