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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Gel patch application
House Institute
Los Angeles, California, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
South Louisiana Ear, Nose, and Throat
Mandeville, Louisiana, United States
Mass Eye and Ear
Boston, Massachusetts, United States
Eardrum closure
The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation.
Time frame: 12 weeks
Device- and procedure-related safety
Incidence of adverse events over the course of the study for each subject.
Time frame: 12 weeks
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): * 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
Time frame: 1 hour
Perforation size - percent area
Size of perforation measured in percent area of eardrum.
Time frame: 1 hour
Perforation size - length and width
Size of perforation measured in mm across length and width of perforation.
Time frame: 1 hour
Perforation location
Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior
Time frame: 12 weeks
Time of procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carolina Ear & Hearing Clinic
Raleigh, North Carolina, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Time taken to apply Perf-Fix in single application
Time frame: 1 hour
Time to heal
Time from Perf-Fix application to tympanic membrane healing
Time frame: 12 weeks
Air-bone gap
Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz
Time frame: 12 weeks
Word recognition
Measurement of hearing ability by percent of words correctly recognized
Time frame: 12 weeks
Tympanometry
Measurement of tympanic membrane integrity as normal or abnormal
Time frame: 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)
Time frame: 1 hour