| NCT ID | NCT05849844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grace Medical, Inc. |
| Condition | Tympanic Membrane Perforation |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2024-01-05 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05849844 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 100 Years, studying Tympanic Membrane Perforation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05849844 currently recruiting?
Yes, NCT05849844 is actively recruiting participants. Contact the research team at robert.stroup@gracemedical.com for enrollment information.
Where is the NCT05849844 trial being conducted?
This trial is being conducted at Farmington Hills, United States, Memphis, United States.
Who is sponsoring the NCT05849844 clinical trial?
NCT05849844 is sponsored by Grace Medical, Inc.. The trial plans to enroll 45 participants.