Tympanic Membrane PerforationNCT06083181
Perf-Fix Study for Chronic Tympanic Membrane Repair
A study testing Perf-Fix Otologic Gel Patch in people with Tympanic Membrane Perforation, run by Tympanogen at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Perf-Fix Otologic Gel Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Apr 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mass Eye and Ear
Boston, Massachusetts, 02114
House Institute
Los Angeles, California, 90017
Advanced ENT & Allergy
Louisville, Kentucky, 40220
South Louisiana Ear, Nose, and Throat
Mandeville, Louisiana, 70471
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Carolina Ear & Hearing Clinic
Raleigh, North Carolina, 27609
Virginia Commonwealth University
Richmond, Virginia, 23219
About this study
Official 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
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.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Perf-Fix Otologic Gel Patch
- Keywords
- tympanic membrane, eardrum, pediatric, tympanoplasty, myringoplasty
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perf-Fix Otologic Gel PatchDevice
Also called Perf-Fix
Gel patch application
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treatment group receives one application of Perf-Fix Receives: Device: Perf-Fix Otologic Gel Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eardrum closure
The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation.
Measured: 12 weeks
Device- and procedure-related safety
Incidence of adverse events over the course of the study for each subject.
Measured: 12 weeks
Secondary outcomes (10)
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
Measured: 1 hour
Perforation size - percent area
Size of perforation measured in percent area of eardrum.
Measured: 1 hour
Perforation size - length and width
Size of perforation measured in mm across length and width of perforation.
Measured: 1 hour
Perforation location
Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior
Measured: 12 weeks
Time of procedure
Time taken to apply Perf-Fix in single application
Measured: 1 hour
Time to heal
Time from Perf-Fix application to tympanic membrane healing
Measured: 12 weeks
Air-bone gap
Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz
Measured: 12 weeks
Word recognition
Measurement of hearing ability by percent of words correctly recognized
Measured: 12 weeks
Tympanometry
Measurement of tympanic membrane integrity as normal or abnormal
Measured: 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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start5 Apr 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tympanogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083181
- Sponsor's protocol ID
- TYMP001
- Other IDs
- 2SB1DC018255-02, 1203
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06083181
- Acronym / sponsor ID
- TYMP001
- Conditions
- Tympanic Membrane Perforation
- Keywords
- tympanic membrane, eardrum, pediatric, tympanoplasty, myringoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- TympanogenIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), NAMSA
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Perf-Fix Otologic Gel PatchTreatment group receives one application of Perf-Fix |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perf-Fix Otologic Gel PatchAlso: Perf-FixGel patch application | Device | Treatment group |
Primary outcome
Eardrum closure
Time frame: 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
Time frame: 12 weeks
Incidence of adverse events over the course of the study for each subject.
10 secondary outcomes
Procedural success
Time frame: 1 hour
Perforation size - percent area
Time frame: 1 hour
Perforation size - length and width
Time frame: 1 hour
Perforation location
Time frame: 12 weeks
Time of procedure
Time frame: 1 hour
Time to heal
Time frame: 12 weeks
Air-bone gap
Time frame: 12 weeks
Word recognition
Time frame: 12 weeks
Tympanometry
Time frame: 12 weeks
Procedure tolerability
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perf-Fix Otologic Gel Patch in people with Tympanic Membrane Perforation, run by Tympanogen at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eardrum closure (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.