Tympanoseal (Tympanic Membrane Device) Clinical Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 100
Healthy Volunteers: t
View:
• 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
Locations
United States
Michigan
Michigan Ear Institute
RECRUITING
Farmington Hills
Tennessee
Methodist Le Bonheur
RECRUITING
Memphis
Contact Information
Primary
Robert Stroup
robert.stroup@gracemedical.com
901-386-0990
Time Frame
Start Date: 2024-01-05
Estimated Completion Date: 2026-04-20
Participants
Target number of participants: 45
Treatments
Experimental: Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Related Therapeutic Areas
Sponsors
Leads: Grace Medical, Inc.