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| ID | Type | Description | Link |
|---|---|---|---|
| 2SB1DC018255-02 | U.S. NIH Grant/Contract | View source | |
| 1203 | Other Grant/Funding Number | VA Catalyst |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| NAMSA | OTHER |
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The purpose of the study is to assess the effectiveness of Perf-Fix as a gel patch to aid in the natural healing process to close chronic, >25% tympanic membrane perforation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Treatment group receives one application of Perf-Fix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perf-Fix Otologic Gel Patch | Device | Gel patch application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eardrum closure | The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation. | 12 weeks |
| Device- and procedure-related safety | Incidence of adverse events over the course of the study for each subject. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Perf-Fix is successfully applied by the clinician to the subject's eardrum perforation, measured as Yes/No. Procedural Success (ALL steps accomplished):
Procedural Failure (including but not limited to):
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Institute | Los Angeles | California | 90017 | United States | ||
| Advanced ENT & Allergy |
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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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| 1 hour |
| Perforation size - percent area | Size of perforation measured in percent area of eardrum. | 1 hour |
| Perforation size - length and width | Size of perforation measured in mm across length and width of perforation. | 1 hour |
| Perforation location | Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior | 12 weeks |
| Time of procedure | Time taken to apply Perf-Fix in single application | 1 hour |
| Time to heal | Time from Perf-Fix application to tympanic membrane healing | 12 weeks |
| Air-bone gap | Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz | 12 weeks |
| Word recognition | Measurement of hearing ability by percent of words correctly recognized | 12 weeks |
| Tympanometry | Measurement of tympanic membrane integrity as normal or abnormal | 12 weeks |
| Procedure tolerability | Assess pain/discomfort using Visual Analogue Scale before and after each Perf-Fix application procedure on a scale 0-10 (0=no pain, 10=unbearable pain) | 1 hour |
| Louisville |
| Kentucky |
| 40220 |
| United States |
| South Louisiana Ear, Nose, and Throat | Mandeville | Louisiana | 70471 | United States |
| Mass Eye and Ear | Boston | Massachusetts | 02114 | United States |
| Carolina Ear & Hearing Clinic | Raleigh | North Carolina | 27609 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |