RecruitingNot Applicable

Tympanoseal Clinical Study

United States45 participantsStarted 2024-01-05

Plain-language summary

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.

Who can participate

Age range2 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Number of participants with healed tympanic membrane perforations.

Timeframe: 12 weeks

Trial details

NCT IDNCT05849844

SponsorGrace Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-20

Contact for this trial

Robert Stroup

901-386-0990 robert.stroup@gracemedical.com

View on ClinicalTrials.gov More Tympanic Membrane Perforation trials