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RECRUITING
NCT05849844
NA

Tympanoseal Clinical Study

Sponsor: Grace Medical, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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