Otitis Media AcuteNCT04722770
Clinical Development of Deep Learning for the OtoSight
An observational study of Otitis Media Acute, run by PhotoniCare, Inc. at 1 site in United States.
Trial summary
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media Acute
- What is being tested?
- PhotoniCare OtoSight Middle Ear Scope
- Type of treatment
- Medical device
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 31 Aug 2023
- 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 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children presenting to the pediatric clinic with suspected ear infection
Who may be able to join
- Pediatric patients presenting for an office visit with ear-related complaints
Who cannot join
- Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.
- Conditions
- Otitis Media Acute
- Being tested
- PhotoniCare OtoSight Middle Ear Scope
- Keywords
- Ear Infection, Otitis Media, Otitis Media with Effusion, Machine Learning
- Medical subject headings
- Otitis Media, Otitis, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotoniCare OtoSight Middle Ear ScopeDevice
PhotoniCare OtoSight imaging using a near-infrared laser
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with possible ear infections | Pediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight. Receives: Device: PhotoniCare OtoSight Middle Ear Scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
PhotoniCare OtoSight imaging exam
Optical coherence tomography imaging to evaluate the middle ear.
Measured: 1-5 minutes; at first and only study visit
Secondary outcomes (1)
Adverse events
Rate of adverse events
Measured: 15-30 minutes; at first and only study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start19 Jan 2021
- Primary completion2 Sep 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media AcuteStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhotoniCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Ryan Shelton, PhD, Principal investigator, PhotoniCare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722770
- Sponsor's protocol ID
- 000002
- Other IDs
- R44DC017422
- Status last verified
- May 2023
- First submitted
- 20 Jan 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
- ClinicalTrials.gov ID
- NCT04722770
- Acronym / sponsor ID
- 000002
- Conditions
- Otitis Media Acute
- Keywords
- Ear Infection, Otitis Media, Otitis Media with Effusion, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- PhotoniCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Jan 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.
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with possible ear infections | – | Device: PhotoniCare OtoSight Middle Ear ScopePediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight. |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children presenting to the pediatric clinic with suspected ear infection
Key inclusion criteria (1 listed)
- Pediatric patients presenting for an office visit with ear-related complaints
Key exclusion criteria (1 listed)
- Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)
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 |
|---|---|---|
| PhotoniCare OtoSight Middle Ear ScopePhotoniCare OtoSight imaging using a near-infrared laser | Device | Pediatric patients with possible ear infections |
Primary outcome
PhotoniCare OtoSight imaging exam
Time frame: 1-5 minutes; at first and only study visit
Optical coherence tomography imaging to evaluate the middle ear.
1 secondary outcome
Adverse events
Time frame: 15-30 minutes; at first and only study visit
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 23 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Otitis Media Acute
Active, not recruiting
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Acute Otitis Media (AOM)
Active, not recruitingObservational study
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Nasopharyngeal Colonization and Acute Otitis Media
Not yet recruitingPhase 4
Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children
Acute Otitis Media, AOM - Acute Otitis Media
Recruiting
Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds
Acute Otitis Media (AOM), Upper Respiratory Infection
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.
Ryan Shelton, PhD principal investigator
PhotoniCare, Inc.
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 Otitis Media Acute, run by PhotoniCare, Inc. at 1 site in United States.
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 23 Jan 2024. 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 United States. 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?
PhotoniCare OtoSight imaging exam (time frame: 1-5 minutes; at first and only study visit). 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 23 Jan 2024.