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Not Yet Recruiting
NCT05741333
In-Office Clinical Study of the Solo+ TTD
Conditions: Ear Infection, Otitis Media
Sex: All
Ages: 6 Months – 13 Years
Phase: NA
Enrollment: 66
Sponsor: AventaMed DAC
Summary
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
Eligibility Criteria
Inclusion Criteria:Patients aged ≥6 months to <13 yearsPlanned tympanostomy tube insertionPatient is able to commit to the follow-up visits and assessmentsExclusion Criteria:Anatomy that precludes sufficient visualization of the tympanic membraneAnatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTDNarrow ear canalsCongenital or craniofacial abnormalities affecting the earNo baseline audiometry or tympanometryFamilial history of insensitivity to anesthetic componentsPatient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
Source: ClinicalTrials.gov (NCT05741333). StuddyBuddy aggregates publicly available trial information.
