Tympanoseal Clinical Study

Tympanic Membrane Perforation Clinical Trial

Official title:

Tympanoseal (Tympanic Membrane Device) Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849844
• Other study ID #: 2022.01
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: April 20, 2026

Study information

• Verified date: March 2024
• Source: Grace Medical, Inc.
• Contact: Robert Stroup
• Phone: 901-386-0990
• Email: robert.stroup[@]gracemedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 20, 2026
• Est. primary completion date: April 20, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

Device:
• Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure

Locations

Country	Name	City	State
United States	Methodist Le Bonheur	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Grace Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with healed tympanic membrane perforations.	The purpose of this investigational study is to assess the safety of Tympanoseal when used during the healing process. Subject will be observed during the study and the the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator.	12 weeks
Secondary	Number of participants with treatment-related adverse events	Determine if any adverse events occur during presence of material on tympanic membrane.	12 weeks