Middle Ear Effusion, Otitis Media
Conditions
Keywords
Tympanostomy Tube, Ventilation Tube, Grommet, Otitis Media, Middle Ear Effusion
Brief summary
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
Interventions
DEVICESolo TTD
Placement of tympanostomy tube with Solo TTD
Sponsors
AventaMed DAC
University Hospitals of Derby and Burton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Basic Inclusion Criteria: * Listed for bilateral tympanostomy tube insertion only Basic
Exclusion criteria
* Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place. * Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD * Patients in whom a reliable audiogram is not possible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Device Success | Intraoperative | Number of ears in which tube placement is achieved with the Solo TTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion from moderate sedation | Intraoperative | Number of patients requiring conversion from moderate sedation to general anaesthesia |
Countries
United Kingdom
Contacts
Primary ContactMaria Koufali
Backup ContactOlive O'Driscoll
Outcome results
None listed