NCT06083181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

September 11, 2023

Last Update Submit

April 13, 2026

Conditions

Tympanic Membrane Perforation

Keywords

tympanic membraneeardrumpediatrictympanoplastymyringoplasty

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (10)

  • Procedural success

    1 hour

  • Perforation size - percent area

    1 hour

  • Perforation size - length and width

    1 hour

  • Perforation location

    12 weeks

  • Time of procedure

    1 hour

  • +5 more secondary outcomes

Study Arms (1)

Treatment group

EXPERIMENTAL

Treatment group receives one application of Perf-Fix

Device: Perf-Fix Otologic Gel Patch

Interventions

Perf-Fix Otologic Gel PatchDEVICE

Gel patch application

Also known as: Perf-Fix
Treatment group

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

House Institute

Los Angeles, California, 90017, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40220, United States

Location

South Louisiana Ear, Nose, and Throat

Mandeville, Louisiana, 70471, United States

Location

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Carolina Ear & Hearing Clinic

Raleigh, North Carolina, 27609, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

October 13, 2023

Study Start

April 5, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(7)