Active — Not RecruitingNot Applicable

In-Office Clinical Study of the Solo+ TTD

United States66 participantsStarted 2023-03-30

Plain-language 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.

Who can participate

Age range6 Months – 13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged ≥6 months to \<13 years * Planned tympanostomy tube insertion * Patient is able to commit to the follow-up visits and assessments Exclusion Criteria: * Anatomy that precludes sufficient visualization of the tympanic membrane * Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD * Narrow ear canals * Congenital or craniofacial abnormalities affecting the ear * No baseline audiometry or tympanometry * Familial history of insensitivity to anesthetic components * Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

What they're measuring

Procedure Success

Timeframe: Intra-operative

Rate of Adverse Events

Timeframe: 24 months

Trial details

NCT IDNCT05741333

SponsorAventaMed DAC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

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