Tympanoseal Clinical Study

Launched by GRACE MEDICAL, INC. · May 8, 2023

Keywords

ClinConnect Summary

The Tympanoseal Clinical Study is exploring a new device called Tympanoseal, which is designed to help heal the eardrum (tympanic membrane) after it has been injured or after the removal of a tube that was placed in the ear. The study aims to see if this device can provide a supportive structure, like a scaffold, that aids the healing process. It is currently open to participants of all ages, from as young as 2 years to adults, who have a specific type of eardrum perforation or have had a tympanostomy tube that needs to be removed.

To be eligible for the trial, participants must have a perforation that is less than 5 mm and not located on the edge of the eardrum. They should also be able to provide consent and follow the study's requirements. However, those with certain ear infections, conditions like cholesteatoma, or those who are taking specific medications may not qualify. If you join the study, you will receive the Tympanoseal device, and the research team will monitor your progress to see how well it helps your eardrum heal. This trial is an important step in finding new treatments for eardrum injuries, and your participation could help advance medical knowledge in this area.

Gender

ALL

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