ACTIVE_NOT_RECRUITING

Perf-Fix Study for Chronic Tympanic Membrane Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-04
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06083181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide informed consent, legally authorized representative (LAR) consent, or LAR consent and assent when age appropriate
  2. * Females and males at least 5 years old
  3. * Perforation involves \>25% of the tympanic membrane
  4. * Perforation has not spontaneously closed after 4 weeks of watchful waiting
  5. * Perforation is not actively healing
  6. * Perforation can be visualized by an endoscope or microscope
  7. * Ear wax does not occlude the perforation
  1. * Perforation is marginal (a perforation that has an area with no tympanic membrane between the perforation and the bony canal)
  2. * Active otitis media, with or without effusion
  3. * Otorrhea from the middle ear for more than 3 months
  4. * History of cleft palate
  5. * Receiving radiation therapy or taking corticosteroids, immunosuppressive agents, or chemotherapy
  6. * Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid ear drops
  7. * Current bacterial or viral infection
  8. * Fever (Temperature \>100°F) at time of index procedure
  9. * Diagnosed with cholesteatoma mass in the tympanic cavity
  10. * Known history of malignant ear canal tumors within 3 years of screening for eligibility
  11. * Abrasions/lacerations to the external auditory canal
  12. * Significant medical condition that could prevent full participation in the procedures required for the study
  13. * Investigator feels the subject will be unable to cooperate with the application procedure
  14. * Parent/LAR feels the subject will be unable to cooperate with the application procedure
  15. * Allergy to shellfish
  16. * Known to be or could be pregnant
  17. * Adults lacking capacity to consent

Contacts and Locations

Study Locations (Sites)

House Institute
Los Angeles, California, 90017
United States
Advanced ENT & Allergy
Louisville, Kentucky, 40220
United States
South Louisiana Ear, Nose, and Throat
Mandeville, Louisiana, 70471
United States
Mass Eye and Ear
Boston, Massachusetts, 02114
United States
Carolina Ear & Hearing Clinic
Raleigh, North Carolina, 27609
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Tympanogen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • tympanic membrane
  • eardrum
  • pediatric
  • tympanoplasty
  • myringoplasty

Additional Relevant MeSH Terms

  • Tympanic Membrane Perforation