N/A
N=25
Tympanoseal (Tympanic Membrane Device) Clinical Study
Tympanic Membrane Perforation
Bottom Line
View on ClinicalTrials.gov: NCT02918942 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Serious Adverse Events — 0 Serious Adverse Event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tympanoseal (Device)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Grace Medical, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events |
— | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events |
14 | — |
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
- 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.