RadiographyPARADIS_1NCT05076188
PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS
An observational study of Radiography and Emergencies, run by Poitiers University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiography, Emergencies, Diagnostic
- What is being tested?
- Emergency radiography
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Radiographer : a health practionner with official autorisation to use X-ray imagery.
Who may be able to join
- Working in an emergency radiography department Volunteer to participate in the study
Who cannot join
- Planned departure from the establishment within 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Radiography, Emergencies, Diagnostic
- Being tested
- Emergency radiography
- Medical subject headings
- Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency radiographyDiagnostic test
The intervention is to determine how the radiographer classify emergency radiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the radiographers' diagnostic performance to issue an advisory opinion to X-ray reading of the appendicular skeleton in emergency department
The primary outcome measure evaluation radiographers' diagnostic will use accurancy, sensibility and specificity.
Measured: 2 hours
Secondary outcomes (3)
Quantify the proportion of radiographers reaching the goal of 90% accurancy
This is a proportion in % of performance radiographers' diagnosctic treshold
Measured: 4 months
Quantify and qualify Radiographers diagnostic changes before and after the in house training.
This a proportion in % about the progression of performance radiographers'diagnostic in the formation.
Measured: 4 months
Evaluate the performance of the association of AI and radiographer after training
Thiis output is the difference between accurancy, sensibility and sensitivity with or without IA.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiographyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076188
- Sponsor's protocol ID
- Paradis_1
- Acronym
- PARADIS_1
- Status last verified
- Mar 2021
- First submitted
- 30 Sep 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS
- ClinicalTrials.gov ID
- NCT05076188
- Acronym / sponsor ID
- PARADIS_1 / Paradis_1
- Conditions
- Radiography, Emergencies, Diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Radiographer : a health practionner with official autorisation to use X-ray imagery.
Key inclusion criteria (1 listed)
- Working in an emergency radiography department Volunteer to participate in the study
Key exclusion criteria (1 listed)
- Planned departure from the establishment within 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency radiographyThe intervention is to determine how the radiographer classify emergency radiography. | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
Quantify the proportion of radiographers reaching the goal of 90% accurancy
Time frame: 4 months
Quantify and qualify Radiographers diagnostic changes before and after the in house training.
Time frame: 4 months
Evaluate the performance of the association of AI and radiographer after training
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiography and Emergencies, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.