Tympanoseal (Tympanic Membrane Device) Clinical Study

Grace Medical

Status

Completed

Conditions

Tympanic Membrane Perforation

Treatments

Device: Tympanoseal

Study type

Interventional

Funder types

Industry

Identifiers

NCT02918942

2015.01

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients over 2 years of age at enrollment
Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
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

Exclusion criteria

Active otorrhea or otitis media
History of cholesteatoma
Perforations on the edge of the tympanic membrane
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
Subject is taking systemic corticosteroids
Subject requires continued use of any type of topical otic medication