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Tympanoseal Clinical Study
RecruitingHealthy volunteers welcome
Tympanoseal (Tympanic Membrane Device) Clinical Study
Who can join
Ages 2 to 100 · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.
What is being tested
- Tympanoseal (device)
Sponsor: Grace Medical, Inc. · Participants: 45 · Started: Jan 5, 2024
Contact the study team
- Robert Stroup · Phone: 901-386-0990
Official record on ClinicalTrials.gov — NCT05849844
Locations in the U.S.
| Michigan | Michigan Ear Institute, Farmington Hills |
| Tennessee | Methodist Le Bonheur, Memphis |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.