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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

Sponsor: Grace Medical, Inc. · Participants: 45 · Started: Jan 5, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05849844

Locations in the U.S.

MichiganMichigan Ear Institute, Farmington Hills
TennesseeMethodist Le Bonheur, Memphis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.