An observational study in Otitis Media, sponsored by PhotoniCare, Inc.. Completed at 2 sites in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-22.
Sponsored by PhotoniCare, Inc. · Observational
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 110 is below the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →PhotoniCare, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.
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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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight
Device: OtoSight Middle Ear Scope
OtoSight imaging using a near-infrared laser
OtoSight imaging exam
Optical coherence tomography imaging to evaluate the middle ear.
Time frame: 1-5 minutes
Adverse events
Rate of adverse events
Time frame: Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in Apr 2021, 24 months.
Of 22 observational studies under Otitis Media, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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