Tympanic Membrane Perforation
Conditions
Keywords
tympanic membrane, eardrum, pediatric, tympanoplasty, myringoplasty
Brief summary
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.
Interventions
DEVICEPerf-Fix Otologic Gel Patch
Gel patch application
Sponsors
Tympanogen
National Institute on Deafness and Other Communication Disorders (NIDCD)
NAMSA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide informed consent, legally authorized representative (LAR) consent, or LAR consent and assent when age appropriate * Females and males at least 5 years old * Perforation involves \>25% of the tympanic membrane * Perforation has not spontaneously closed after 4 weeks of watchful waiting * Perforation is not actively healing * Perforation can be visualized by an endoscope or microscope * Ear wax does not occlude the perforation
Exclusion criteria
* Perforation is marginal (a perforation that has an area with no tympanic membrane between the perforation and the bony canal) * Active otitis media, with or without effusion * Otorrhea from the middle ear for more than 3 months * History of cleft palate * Receiving radiation therapy or taking corticosteroids, immunosuppressive agents, or chemotherapy * Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid ear drops * Current bacterial or viral infection * Fever (Temperature \>100°F) at time of index procedure * Diagnosed with cholesteatoma mass in the tympanic cavity * Known history of malignant ear canal tumors within 3 years of screening for eligibility * Abrasions/lacerations to the external auditory canal * Significant medical condition that could prevent full participation in the procedures required for the study * Investigator feels the subject will be unable to cooperate with the application procedure * Parent/LAR feels the subject will be unable to cooperate with the application procedure * Allergy to shellfish * Known to be or could be pregnant * Adults lacking capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eardrum closure | 12 weeks | The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation. |
| Device- and procedure-related safety | 12 weeks | Incidence of adverse events over the course of the study for each subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 1 hour | Perf-Fix is successfully applied by the clinician to the subject's eardrum perforation, measured as Yes/No. Procedural Success (ALL steps accomplished): * complete device preparation * apply device to tympanic membrane perforation * complete curing process using light guide and curing light * visualize cured device on tympanic membrane perforation * subject recovers from procedure Procedural Failure (including but not limited to): * inability to apply device to tympanic membrane perforation * device does not adhere to tympanic membrane * behavioral intolerance to procedure * all steps for Procedural Success not completed |
| Perforation size - percent area | 1 hour | Size of perforation measured in percent area of eardrum. |
| Perforation size - length and width | 1 hour | Size of perforation measured in mm across length and width of perforation. |
| Perforation location | 12 weeks | Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior |
| Time of procedure | 1 hour | Time taken to apply Perf-Fix in single application |
| Time to heal | 12 weeks | Time from Perf-Fix application to tympanic membrane healing |
| Air-bone gap | 12 weeks | Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz |
| Word recognition | 12 weeks | Measurement of hearing ability by percent of words correctly recognized |
| Tympanometry | 12 weeks | Measurement of tympanic membrane integrity as normal or abnormal |
| Procedure tolerability | 1 hour | 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) |
Countries
United States
Outcome results
None listed