Tympanoseal Clinical Study

Grace Medical

Status: Enrolling

Conditions: Tympanic Membrane Perforation

Treatments: Device: Tympanoseal

Study type: Interventional

Funder types: Industry

Identifiers

NCT05849844

2022.01

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: 45 estimated patients

Sex: All

Ages: 2 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Tympanoseal

Experimental group

Description:

All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.

Treatment:

Device: Tympanoseal