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โ† Trials
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Tympanoseal Clinical Study

RecruitingNAAges 2 Years - 100 YearsAllGrace Medical, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Tympanoseal
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Where

2 sites
Michigan Ear Institute
Farmington Hills, United States
Methodist Le Bonheur
Memphis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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