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

tympanic membrane perforation

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Tympanoseal for people with tympanic membrane perforation. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 2 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETympanoseal

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

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NCT05849844

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