Actively Recruiting
Tympanoseal Clinical Study
Led by Grace Medical, Inc. · Updated on 2024-10-15
45
Participants Needed
2
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tympanoseal Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Ability for subject to comply with the requirements of the study
You will not qualify if you...
- 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
- Condition or abnormality that compromises patient safety or data quality as judged by Investigator
- Current use of systemic/oral corticosteroids
- Need for continued use of any topical otic medication to the ear(s) with Tympanoseal
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Michigan Ear Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
2
Methodist Le Bonheur
Memphis, Tennessee, United States, 38103
Actively Recruiting
Research Team
R
Robert Stroup
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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