Ear Infection, Otitis Media
Conditions
Brief 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.
Detailed description
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.
Interventions
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Sponsors
AventaMed DAC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Intra-operative | Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears |
| Rate of Adverse Events | 24 months | Incidence and nature of device- or procedure-related adverse events |
Countries
United States
Contacts
STUDY_CHAIRMatija Daniel
Queen's Medical Center
Outcome results
None listed