Tympanoseal Clinical Study
ConditionTympanic Membrane Perforation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-100
SponsorGrace Medical, Inc.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Tympanoseal
DeviceAll subjects will receive the Tympanoseal device that will be placed during a surgical procedure
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: TympanosealExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 weeksSecondary outcomes
1
Number of participants with treatment-related adverse events
Determine if any adverse events occur during presence of material on tympanic membrane.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov