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Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device

Recruitingn/aAges 6 Months - anyAllAventaMed DAC
NCT07029997 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subject and/or Parent/Guardian is able to understand the information document and (depending in the country's legislation) does not object participating or is willing to provide documented informed consent * Subject was or will be treated, or had a treatment attempted with the study device. Exclusion Criteria: * None
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What it tests

  • Solo+ Tympanostomy Tube Device (Solo+ TTD)
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Where

1 site
I.R.C.C.S. Materno Infantile Burlo Garofolo
Trieste, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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