Study Results
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View full resultsBasic Information
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COMPLETED
25 participants
INTERVENTIONAL
2016-10-04
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tympanoseal
All subjects will receive the Tympanoseal device.
Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Interventions
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Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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Grace Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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UT Southwestern Medical Center
Plano, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2015.01
Identifier Type: -
Identifier Source: org_study_id
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