Using Tympanoseal to help heal ear drum perforations
Tympanoseal (Tympanic Membrane Device) Clinical Study
This study is testing if a new gel called Tympanoseal can help heal holes in the eardrum for people who have had ear tubes removed or have had ear injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 2 Years to 100 Years |
| Sex | All |
| Sponsor | Grace Medical, Inc. Industry-sponsored |
| Locations | 2 sites (Farmington Hills, Michigan and 1 other locations) |
| Trial ID | NCT05849844 on ClinicalTrials.gov |
What this trial studies
This investigational study evaluates the effectiveness of Tympanoseal, a sodium/calcium alginate gel, as a scaffold for healing tympanic membrane perforations. The study focuses on patients who have had tympanostomy tubes removed or have experienced traumatic injuries to the tympanic membrane. Participants will be monitored for safety and the gel's ability to occlude perforations during the healing process. The goal is to provide an alternative to traditional grafting techniques for tympanic membrane repair.
Who should consider this trial
Good fit: Ideal candidates include individuals over 2 years old with a tympanic membrane perforation less than 5 mm that is not located on the edge.
Not a fit: Patients with active ear infections, specific types of perforations, or those requiring ongoing ear medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive and effective method for healing tympanic membrane perforations.
How similar studies have performed: While similar approaches have been explored, the use of Tympanoseal as a scaffold for tympanic membrane healing is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients over 2 years of age at enrollment 2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane. 3. Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study Exclusion Criteria: 1. Active otorrhea or otitis media 2. Otorrhea or otitis media within 4 weeks prior to the operation 3. History of cholesteatoma 4. Perforations on the edge of the tympanic membrane 5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data 6. Subject is taking systemic/oral corticosteroids 7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal
Where this trial is running
Farmington Hills, Michigan and 1 other locations
- Michigan Ear Institute — Farmington Hills, Michigan, United States (Recruiting)
- Methodist Le Bonheur — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Robert Stroup
- Email: robert.stroup@gracemedical.com
- Phone: 901-386-0990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.