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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solo+ Tympanostomy Tube Device (Solo+ TTD) | Experimental | The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solo+ Tympanostomy Tube Device (Solo+ TTD) | Device | The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears | Intra-operative |
| Rate of Adverse Events | Incidence and nature of device- or procedure-related adverse events | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matija Daniel | Queen's Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Head & Neck Surgery | Alexander City | Alabama | 35010 | United States | ||
| North Alabama ENT |
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| ID | Term |
|---|---|
| D010031 | Otitis |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Huntsville |
| Alabama |
| 35801 |
| United States |
| East Alabama ENT | Opelika | Alabama | 36801 | United States |
| Sacramento ENT | Sacramento | California | 95661 | United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40220 | United States |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | United States |
| South Carolina ENT | Columbia | South Carolina | 29203 | United States |