N/A
Completed N=25
Tympanoseal (Tympanic Membrane Device) Clinical Study
Tympanic Membrane Perforation
Source: ClinicalTrials.gov NCT02918942 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Serious Adverse Events — 0 Serious Adverse Event
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events |
— | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events |
14 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02918942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.