An interventional study of Solo+ Tympanostomy Tube Device (Solo+ TTD) in Ear Infection and Otitis Media, sponsored by AventaMed DAC. Active, not recruiting at 7 sites in United States. Open to participants aged 6 Months to 13 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by AventaMed DAC · Not applicable, Interventional, and Treatment
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.
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to \<13 years.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 66 is below the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →AventaMed DAC is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Compared within Otitis Media, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Otitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.
Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Procedure Success
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Time frame: Intra-operative
Rate of Adverse Events
Incidence and nature of device- or procedure-related adverse events
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Mar 2026, 35 months.
Of 45 interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 35 months is close to that.
Primary completion moved once since we started tracking on Sep 25, 2026: May 2026 → Mar 2026, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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