Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Grace Medical, Inc.
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.
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients over 2 years of age at enrollment
Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
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
You may not be if
Active otorrhea or otitis media
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 corticosteroids
Subject requires continued use of any type of topical otic medication
