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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.
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 - No limit years
Sex
ALL
Healthy Volunteers
No
UT Southwestern Medical Center
Plano, Texas, United States
Start Date
October 4, 2016
Primary Completion Date
September 30, 2021
Completion Date
September 30, 2021
Last Updated
October 15, 2024
25
ACTUAL participants
Tympanoseal
DEVICE
Lead Sponsor
Grace Medical, Inc.
NCT06083181
NCT03837665
NCT02019888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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