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The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solo Tympanostomy Tube Device | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solo TympanostomyTube Device | Device | The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device | The number of ears in which the Solo Tympanostomy Tube Device tube is placed | Intra-operative |
| Rate of Adverse Events | The number and type of Adverse Events | Intra-operative, 2-6 weeks post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olive O'Driscoll | Contact | +353 21 492 8980 | clinical@aventamed.com |
| Name | Affiliation | Role |
|---|---|---|
| Matija Daniel | Queen's Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Burlo-Garofolo | Recruiting | Trieste | Italy |
There is no plan to make IPD available to other researchers
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| ID | Term |
|---|---|
| D010031 | Otitis |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Royal Derby Hospital | Recruiting | Derby | United Kingdom |
| Queen's Medical Centre | Completed | Nottingham | United Kingdom |