Middle Ear EffusionNCT07454512
Evaluating Laser Otoscope for Middle Ear Effusion Detection
An observational study of Middle Ear Effusion and Otitis Media, run by MSTATT LLC at 1 site in United States.
Trial summary
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are: -Accuracy and usability of doctors using laser otoscopes Participants already having ear tubes placed will have an… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Middle Ear Effusion, Otitis Media
- What is being tested?
- Laser otoscope examination
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Sep 2026
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients ages 6 months to 18 years who are scheduled to undergo unilateral or bilateral myringotomy with ear tube placement (tympanostomy) as part of their standard clinical care. Eligible participants will be identified prior to surgery based on clinical scheduling and medical history.
Who may be able to join
- Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement
- Between the ages of 6 months to 18 years at the time of consent
- Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection
Who cannot join
- History of prior ear tube placement
- Anatomical abnormalities of the tympanic membrane or ear canal
- Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures
- Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44106
John O'Neill, 216-445-8175, ONEILLJ2@ccf.org
Brandon Hopkins, M.D.
About this study
Official title: Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:
-Accuracy and usability of doctors using laser otoscopes
Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
- Conditions
- Middle Ear Effusion, Otitis Media
- Being tested
- Laser otoscope examination
- Medical subject headings
- Otitis Media with Effusion, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser otoscope examinationDevice
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.
| Study group | Role | What they receive |
|---|---|---|
| Investigational cohort | Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement. Receives: Device: Laser otoscope examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence
The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE.
Measured: From enrollment to data collection at tympanostomy typically at 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear EffusionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MSTATT LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), The Cleveland Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454512
- Sponsor's protocol ID
- 1R43DC022815-01A1
- Other IDs
- 1R43DC022815-01A1
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07454512
- Acronym / sponsor ID
- 1R43DC022815-01A1
- Conditions
- Middle Ear Effusion, Otitis Media
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MSTATT LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), The Cleveland Clinic
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Mar 2026 (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 goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:
-Accuracy and usability of doctors using laser otoscopes
Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational cohort | – | Device: Laser otoscope examinationPediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients ages 6 months to 18 years who are scheduled to undergo unilateral or bilateral myringotomy with ear tube placement (tympanostomy) as part of their standard clinical care. Eligible participants will be identified prior to surgery based on clinical scheduling and medical history.
Key inclusion criteria (3 listed)
- Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement
- Between the ages of 6 months to 18 years at the time of consent
- Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection
Key exclusion criteria (4 listed)
- History of prior ear tube placement
- Anatomical abnormalities of the tympanic membrane or ear canal
- Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures
- Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.
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 |
|---|---|---|
| Laser otoscope examinationPatients will have short videos taken of their tympanic membranes under white light and laser illumination. | Device | Investigational cohort |
Primary outcome
Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence
Time frame: From enrollment to data collection at tympanostomy typically at 2-3 weeks
The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE.
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 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Middle Ear Effusion and Otitis Media, run by MSTATT LLC 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Mar 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence (time frame: From enrollment to data collection at tympanostomy typically at 2-3 weeks). 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 6 Mar 2026.