At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
Tympanosealdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tympanoseal (Tympanic Membrane Device) Clinical Study
In Brief
A clinical study evaluating Tympanoseal for Tympanic Membrane Perforation. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTympanic Membrane Perforation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartOct 2016
Primary CompletionSep 2021
TodayJul 2026
First PostedSep 29, 2016
Enrollment StartOct 4, 2016
Primary CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.8 years ago
Interventions
Tympanosealdevice
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.