Ear Infection, Otitis Media
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICESolo+ 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
Sponsors
AventaMed DAC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
No
Inclusion criteria
* Listed for bilateral tympanostomy tube insertion
Exclusion criteria
* Anatomy that precludes sufficient visualisation of both the left and right eardrum * Narrow ear canals * Anatomy that precludes safe access to both the left and right eardrum * Membrane \>25% sclerosis * Congenital or craniofacial abnormalities * No available baseline audiometry and tympanometry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device | Intra-operative | The number of ears in which the Solo Tympanostomy Tube Device tube is placed |
| Rate of Adverse Events | 24 months | The number and type of Adverse Events |
Countries
United States
Outcome results
None listed