RecruitingNot Applicable

Tympanoseal Clinical Study

United States45 participantsStarted 2024-01-05

Plain-language 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.

Who can participate

Age range

2 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients over 2 years of age at enrollment
. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
. 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
. Otorrhea or otitis media within 4 weeks prior to the operation
. 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/oral corticosteroids
. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with healed tympanic membrane perforations.

Timeframe: 12 weeks

Trial details

NCT IDNCT05849844

SponsorGrace Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-20

Contact for this trial

Robert Stroup

901-386-0990 robert.stroup@gracemedical.com

View on ClinicalTrials.gov More Tympanic Membrane Perforation trials