Recruiting

Tympanoseal

Sponsor:

Grace Medical, Inc.

Code:

NCT05849844

Conditions

Tympanic Membrane Perforation

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Interventions

Tympanoseal

Study Details

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.

Conditions

Tympanic Membrane Perforation

Study ID

NCT05849844

Start date

Jan 5, 2024

Status verified date

Oct, 2024

Completion date

Apr 20, 2026

Anticipated

Primary completion date

Apr 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

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

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tympanoseal

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

Interventions

Tympanoseal

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

Primary outcome measure

  • Number of participants with healed tympanic membrane perforations. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Michigan Ear Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

Seilesh Babu, MD

Methodist Le Bonheur

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

More Information

Sponsor

Grace Medical, Inc.

Last update posted

Oct 15, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Grace Medical, Inc. on 2024-10-15.