FractureNCT05538403
AI Performance for the Detection of Bone Fractures in Children
An observational study of Fracture, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Fracture
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 30 Dec 2022
- 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 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged less than 2 years old in suspected child abuse setting
Who may be able to join
- aged less than 2 years old
- whole body radiography performed for suspected child abuse setting
- report available with a double blind reading (generalist radiologist and radiologist with expertise in child abuse)
Who cannot join
- Radiograph not interpretable ( poor quality)
- AI not applicable
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital
Montpellier, 34295
Ingrid Millet, PUPH, 0678887174 ext. 33, i-millet@chu-montpellier.fr
About this study
Official title: Assessment of AI Performance for the Detection of Bone Fractures in Children Aged Less Than 2 Years Old in Suspected Child Abuse Setting.
The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs.
The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting.
Read more
These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results.
Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.
- Conditions
- Fracture
- Keywords
- Aged, Radiography, Paediatric imaging, Artificial intelligence, child abuse
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of fracture detected by AI on radiographs
Percentage of fracture detected by AI on radiographs
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 May 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Millet, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538403
- Sponsor's protocol ID
- RECHMPL22_0224
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of AI Performance for the Detection of Bone Fractures in Children Aged Less Than 2 Years Old in Suspected Child Abuse Setting.
- ClinicalTrials.gov ID
- NCT05538403
- Acronym / sponsor ID
- RECHMPL22_0224
- Conditions
- Fracture
- Keywords
- Aged, Radiography, Paediatric imaging, Artificial intelligence, child abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Sep 2022 (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.
The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs.
The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting.
These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results.
Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged less than 2 years old in suspected child abuse setting
Key inclusion criteria (3 listed)
- aged less than 2 years old
- whole body radiography performed for suspected child abuse setting
- report available with a double blind reading (generalist radiologist and radiologist with expertise in child abuse)
Key exclusion criteria (2 listed)
- Radiograph not interpretable ( poor quality)
- AI not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of fracture detected by AI on radiographs
Time frame: 1 day
Percentage of fracture detected by AI on radiographs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Ingrid Millet, PUPH study director
University Hospital, Montpellier
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 Fracture, run by University Hospital, Montpellier 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Millet, PUPH (678887174 ext. 33, i-millet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of fracture detected by AI on radiographs (time frame: 1 day). 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 13 Sep 2022.