RecruitingNot ApplicableNCT05849844
Tympanoseal Clinical Study
Tympanoseal (Tympanic Membrane Device) Clinical Study
Sponsor
Grace Medical, Inc.
Enrollment
45 participants
Start Date
Jan 5, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 2 YearsMax Age: 100 Years
Inclusion Criteria3
- 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 Criteria7
- 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
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Interventions
DEVICETympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05849844