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Tympanoseal Clinical Study
Sponsor: Grace Medical, Inc.
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.
Official title: Tympanoseal (Tympanic Membrane Device) Clinical Study
Key Details
Gender
All
Age Range
2 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-01-05
Completion Date
2026-04-20
Last Updated
2024-10-15
Healthy Volunteers
Yes
Conditions
Interventions
Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure
Locations (2)
Michigan Ear Institute
Farmington Hills, Michigan, United States
Methodist Le Bonheur
Memphis, Tennessee, United States