An interventional study of Solo+ Tympanostomy Tube Device in Ear Infection and Otitis Media, sponsored by AventaMed DAC. Active, not recruiting at 2 sites in United States. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by AventaMed DAC · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 27 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+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure
Device: Solo+ Tympanostomy Tube Device
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Time frame: Intra-operative
Rate of Adverse Events
The number and type of Adverse Events
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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AventaMed DAC