Tympanoseal Clinical Study

Description

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

Tympanic Membrane Perforation

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Study Overview

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Study Details

Study overview

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.

Tympanoseal (Tympanic Membrane Device) Clinical Study

Tympanoseal Clinical Study

Condition
Tympanic Membrane Perforation
Intervention / Treatment

-

Contacts and Locations

Farmington Hills

Michigan Ear Institute, Farmington Hills, Michigan, United States, 48334

Memphis

Methodist Le Bonheur, Memphis, Tennessee, United States, 38103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female patients over 2 years of age at enrollment
  • 2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
  • 3. Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study
  • 1. Active otorrhea or otitis media
  • 2. Otorrhea or otitis media within 4 weeks prior to the operation
  • 3. History of cholesteatoma
  • 4. Perforations on the edge of the tympanic membrane
  • 5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • 6. Subject is taking systemic/oral corticosteroids
  • 7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Ages Eligible for Study

2 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Grace Medical, Inc.,

Study Record Dates

2026-04-20