AI Performance for the Detection of Bone Fractures in Children

NCT ID: NCT05538403

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* Radiograph not interpretable ( poor quality)
* AI not applicable
Minimum Eligible Age

0 Years

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ingrid Millet, PUPH

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University hospital

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ingrid Millet, PUPH

Role: CONTACT

678887174 ext. 33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ingrid Millet, PUPH

Role: primary

0678887174 ext. 33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL22_0224

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES
NCT06467006 NOT_YET_RECRUITING