Tympanoseal Clinical Study
Start Date
1/5/2024
Completion Date
4/20/2026
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.
Detailed Description
This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.
Eligibility Criteria
Age Range: 2 years to 100 years
Interventions
Tympanoseal
Conditions
Locations
Michigan Ear Institute
Farmington Hills, Michigan 48334
United States
Methodist Le Bonheur
Memphis, Tennessee 38103
United States