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The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.
This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tympanoseal | Experimental | All subjects will receive the Tympanoseal device that will be placed during a surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tympanoseal | Device | All subjects will receive the Tympanoseal device that will be placed during a surgical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with healed tympanic membrane perforations. | The purpose of this investigational study is to assess the safety of Tympanoseal when used during the healing process. Subject will be observed during the study and the the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Determine if any adverse events occur during presence of material on tympanic membrane. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Stroup | Contact | 901-386-0990 | robert.stroup@gracemedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Ear Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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| Methodist Le Bonheur | Recruiting | Memphis | Tennessee | 38103 | United States |
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