An interventional study of Tympanoseal in Tympanic Membrane Perforation, sponsored by Grace Medical, Inc.. Recruiting at 2 sites in United States. Open to participants aged 2 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Grace Medical, Inc. · Not applicable, Interventional, and Treatment
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.
45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.
This study's planned enrollment of 45 is below the median of 57 across 31 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →Grace Medical, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Device: Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure
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.
Time frame: 12 weeks
Number of participants with treatment-related adverse events
Determine if any adverse events occur during presence of material on tympanic membrane.
Time frame: 12 weeks
Plan to share: No
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Tympanic Membrane Perforation→
Grace Medical, Inc.