Tympanoseal Clinical Study

Not Applicable

Recruiting

• Conditions: Tympanic Membrane Perforation
• Interventions: Device: Tympanoseal

• Registration Number: NCT05849844
• Lead Sponsor: Grace Medical, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-09
• Study Start: 2024-01-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-04-20
• Study Completion: 2026-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with healed tympanic membrane perforations.	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	12 weeks	Determine if any adverse events occur during presence of material on tympanic membrane.

Trial Locations

Locations (2)

Michigan Ear Institute; 🇺🇸 Farmington Hills, Michigan, United States

Methodist Le Bonheur; 🇺🇸 Memphis, Tennessee, United States