Clinical Study of the Solo+ Tympanostomy Tube Device
Purpose
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
Conditions
- Ear Infection
- Otitis Media
Eligibility
- Eligible Ages
- Between 6 Months and 15 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Solo+ Tympanostomy Tube Device |
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 |
|
Recruiting Locations
More Details
- NCT ID
- NCT04148417
- Status
- Active, not recruiting
- Sponsor
- AventaMed DAC
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.