Tympanoseal Clinical Study
Tympanoseal (Tympanic Membrane Device) Clinical Study
1 other identifier
interventional
45
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2026
CompletedOctober 15, 2024
October 1, 2024
2.3 years
April 13, 2023
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with healed tympanic membrane perforations.
The purpose of this investigational study is to assess the safety of Tympanoseal when used during the healing process. Subject will be observed during the study and the the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator.
12 weeks
Secondary Outcomes (1)
Number of participants with treatment-related adverse events
12 weeks
Study Arms (1)
Tympanoseal
EXPERIMENTALAll subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Interventions
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure
Eligibility Criteria
You may qualify if:
- Male or female patients over 2 years of age at enrollment
- Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
- 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
You may not qualify if:
- Active otorrhea or otitis media
- Otorrhea or otitis media within 4 weeks prior to the operation
- 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/oral corticosteroids
- Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Michigan Ear Institute
Farmington Hills, Michigan, 48334, United States
Methodist Le Bonheur
Memphis, Tennessee, 38103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2023
First Posted
May 9, 2023
Study Start
January 5, 2024
Primary Completion
April 20, 2026
Study Completion
April 20, 2026
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share