Ear InfectionNCT05641285
Diagnostic Utility of Otosight Middle Ear Scope
An observational study of Ear Infection and Middle Ear Infection, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Ear Infection, Middle Ear Infection, Otitis Media
- What is being tested?
- The OtoSight Middle Ear Scope
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses who have no history of ear tube placement.
Who may be able to join
- Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses.
Who cannot join
- Patients who have a history of ear tube placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.
Read the detailed description
The purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.
- Conditions
- Ear Infection, Middle Ear Infection, Otitis Media
- Being tested
- The OtoSight Middle Ear Scope
- Keywords
- Otoscope, Tympanogram
- Medical subject headings
- Otitis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The OtoSight Middle Ear ScopeDevice
The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.
| Study group | Role | What they receive |
|---|---|---|
| Otosight, Otoscope, and Tympanogram | Prospective study using a convenience sample. There will be no group assignment or randomization. There is no intervention planned and therefore, no placebo group or use of controls. Receives: Device: The OtoSight Middle Ear Scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exam Completion Rate
Compare the successful exam completion rate of these three diagnostic tools.
For the Otosight device: presence or absence of visible tympanic membrane, and presence or absence of graph indicating fluid/no fluid in the middle ear.
For tympanogram: presence or absence of interpretable tracing indicating normal tympanic membrane movement, retracted tympanic membrane, or no movement of tympanic membrane.
For the Otoscope: success is visualization of the tympanic membrane versus unable to see tympanic membrane.
Measured: 6 months
Detection of middle ear fluid
Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.
Measured: 6 months
Categorization of middle ear fluid
Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.
Measured: 6 months
Secondary outcomes (1)
Timed Evaluation of Clinic Flow
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic by timing how long it takes for the MA and/or MD to complete the Otosight exam.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start21 Feb 2023
- Primary completion29 Jun 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Messner, Baylor College of Medicine
- Investigators
- Anna Messner, MD, Principal investigator, Baylor College of MedicineYi-Chun Liu, MD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641285
- Sponsor's protocol ID
- H-52641
- Status last verified
- Oct 2024
- First submitted
- 17 Nov 2022
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No one besides the PI, the study staff, the IRB and the sponsor will have access to identifiable research data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media
- ClinicalTrials.gov ID
- NCT05641285
- Acronym / sponsor ID
- H-52641
- Conditions
- Ear Infection, Middle Ear Infection, Otitis Media
- Keywords
- Otoscope, Tympanogram
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Dec 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.
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.
Detailed description
The purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Otosight, Otoscope, and Tympanogram | – | Device: The OtoSight Middle Ear ScopeProspective study using a convenience sample. There will be no group assignment or randomization. There is no intervention planned and therefore, no placebo group or use of controls. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses who have no history of ear tube placement.
Key inclusion criteria (1 listed)
- Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses.
Key exclusion criteria (1 listed)
- Patients who have a history of ear tube placement
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 |
|---|---|---|
| The OtoSight Middle Ear ScopeThe OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. | Device | Otosight, Otoscope, and Tympanogram |
Primary outcome
Exam Completion Rate
Time frame: 6 months
Compare the successful exam completion rate of these three diagnostic tools. For the Otosight device: presence or absence of visible tympanic membrane, and presence or absence of graph indicating fluid/no fluid in the middle ear. For tympanogram: presence or absence of interpretable tracing indicating normal tympanic membrane movement, retracted tympanic membrane, or no movement of tympanic membrane. For the Otoscope: success is visualization of the tympanic membrane versus unable to see tympanic membrane.
Detection of middle ear fluid
Time frame: 6 months
Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.
Categorization of middle ear fluid
Time frame: 6 months
Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.
1 secondary outcome
Timed Evaluation of Clinic Flow
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. No one besides the PI, the study staff, the IRB and the sponsor will have access to identifiable research data.
Related trials for Ear Infection
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
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)
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.
Anna Messner, MD principal investigator
Baylor College of Medicine
Yi-Chun Liu, MD study chair
Baylor College of Medicine
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 Ear Infection and Middle Ear Infection, run by Baylor College of Medicine 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: under way, not looking for participants, as of the sponsor's last update on 31 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Exam Completion Rate (time frame: 6 months). The study lists 3 primary outcomes in all. 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 31 Oct 2024.