Tympanoseal Clinical Study

Recruiting now · Not applicable

Conditions studied: Tympanic Membrane Perforation

In brief

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.

Key facts

Study ID

NCT05849844

Run by

Grace Medical, Inc.

People needed

45

Starts

2024-01-05

Expected to finish

2026-04-20

Last updated by the study team

2024-10-15

Who can join

Age: 2 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female patients over 2 years of age at enrollment
• Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
• 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

You may not qualify if…

• Active otorrhea or otitis media
• Otorrhea or otitis media within 4 weeks prior to the operation
• History of cholesteatoma
• Perforations on the edge of the tympanic membrane
• 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
• Subject is taking systemic/oral corticosteroids
• Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Where it is running

• Michigan Ear Institute — Farmington Hills, Michigan, United States (enrolling)
• Methodist Le Bonheur — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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