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Completed

NCT Number: NCT06083181

Perf-Fix Study for Chronic Tympanic Membrane Repair

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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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases Wounds and Injuries

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

House Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perf-Fix Otologic Gel Patch

Device

Gel patch application

Other names: Perf-Fix

Primary outcomes

  1. Eardrum closure

    Time frame: 12 weeks

    The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation.

  2. Device- and procedure-related safety

    Time frame: 12 weeks

    Incidence of adverse events over the course of the study for each subject.

Secondary outcomes

  1. Procedural success

    Time frame: 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

  2. Perforation size - percent area

    Time frame: 1 hour

    Size of perforation measured in percent area of eardrum.

  3. Perforation size - length and width

    Time frame: 1 hour

    Size of perforation measured in mm across length and width of perforation.

  4. Perforation location

    Time frame: 12 weeks

    Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior

  5. Time of procedure

    Time frame: 1 hour

    Time taken to apply Perf-Fix in single application

  6. Time to heal

    Time frame: 12 weeks

    Time from Perf-Fix application to tympanic membrane healing

  7. Air-bone gap

    Time frame: 12 weeks

    Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz

  8. Word recognition

    Time frame: 12 weeks

    Measurement of hearing ability by percent of words correctly recognized

  9. Tympanometry

    Time frame: 12 weeks

    Measurement of tympanic membrane integrity as normal or abnormal

  10. Procedure tolerability

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Tympanogen

Industry

Collaborators

  • NAMSA
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

A Multicenter, Prospective, Open-label Clinical Trial to Evaluate the Safety and Effectiveness of the Perf-Fix Otologic Gel Patch to Aid in the Repair of Chronic Tympanic Membrane Perforation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2023
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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