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New treatment option for Tympanic Membrane Perforation
Official title Tympanoseal Clinical Study
ClinicalTrials.gov ID: NCT05849844
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 100. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Farmington Hills, Michigan, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Farmington Hills, Michigan, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.