An observational study in Middle Ear Effusion and Otitis Media, sponsored by MSTATT LLC. Not yet recruiting at 1 site in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by MSTATT LLC · Observational
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.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 21 observational studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →This is the only study on the registry with MSTATT LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement.
Device: Laser otoscope examination
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.
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.
Time frame: From enrollment to data collection at tympanostomy typically at 2-3 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Jul 2026, 4 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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