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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. |
|
| 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 Serious Adverse Events | 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 healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. Any serious adverse events (SAE) will be noted. An SAE is defined as any adverse event occurring that results in any of the following outcomes:
| 16 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. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Plano | Texas | 75024 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanoseal | All subjects will receive the Tympanoseal device. Tympanoseal: All subjects received the Tympanoseal device. Tympanoseal was placed during a surgical procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tympanoseal | All subjects will receive the Tympanoseal device. Tympanoseal: All subjects will receive the Tympanoseal device that will be placed during a surgical procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Serious Adverse Events | 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 healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. Any serious adverse events (SAE) will be noted. An SAE is defined as any adverse event occurring that results in any of the following outcomes:
| Posted | Number | Serious Adverse Event | 16 weeks |
|
Adverse event data was gathered at follow up visits which occurred at 4 weeks, 10 weeks, 16 weeks, 20 weeks, 24 weeks, 30 weeks, 36 weeks, 42 weeks, 48 weeks, 54 weeks as needed until the patient exited the study. Follow up visits occurred through study completion, an average of 30 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tympanoseal | All subjects will receive the Tympanoseal device. Tympanoseal: All subjects will receive the Tympanoseal device that will be placed during a surgical procedure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otorrhea | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Stroup | Grace Medical, Inc. | 901-386-0990 | robert.stroup@gracemedical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2017 | Sep 25, 2024 | Prot_000.pdf |
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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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
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| Secondary | Number of Participants With Treatment-related Adverse Events | Determine if any adverse events occur during presence of material on tympanic membrane. | Posted | Number | Participants | 16 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 14 |
| 25 |
| Granulation | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Drainage | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Otitis Externa | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Otitis Media | Ear and labyrinth disorders | Non-systematic Assessment |
|
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