Otitis Media Clinical Trial
Official title:
Post-Market Approval Study of the Solo Tympanostomy Tube Device
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | November 2019 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Nottingham University Hospitals NHS Trust | AventaMed DAC, Derby Hospitals NHS Foundation Trust, Sheffield Children's NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intraoperative Device Success | Number of ears in which tube placement is achieved with the Solo TTD | Intraoperative | |
| Secondary | Conversion from moderate sedation | Number of patients requiring conversion from moderate sedation to general anaesthesia | Intraoperative |
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