Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department

NCT ID: NCT04752891

Last Updated: 2023-03-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2023-03-16

Brief Summary

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

Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

Detailed Description

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

Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ.

Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®).

Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app

Conditions

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

Otitis Media, Suppurative

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AOM diagnosis with app

Group Type EXPERIMENTAL

AOM diagnosis with app

Intervention Type OTHER

the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone

AOM diagnosis without app

Group Type OTHER

AOM diagnosis without app

Intervention Type OTHER

the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AOM diagnosis with app

the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone

Intervention Type OTHER

AOM diagnosis without app

the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained

Exclusion Criteria

A sign (s) of vital distress Trans-tympanic drains

\-
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Fondation Lenval

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

Locations

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

Hôpitaux Pédiatrique de Nice CHU Lenval

Nice, , France

Site Status

Countries

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

France

Other Identifiers

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

20-HPNCL-07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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