RECRUITING

Tympanoseal Clinical Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tympanoseal (Tympanic Membrane Device) Clinical Study

Quick Facts

Study Start:2024-01-05

Study Completion:2026-04-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05849844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female patients over 2 years of age at enrollment 2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane. 3. 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	1. Active otorrhea or otitis media 2. Otorrhea or otitis media within 4 weeks prior to the operation 3. History of cholesteatoma 4. Perforations on the edge of the tympanic membrane 5. 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 6. Subject is taking systemic/oral corticosteroids 7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Inclusion Criteria

Exclusion Criteria

1. Male or female patients over 2 years of age at enrollment
2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
3. 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

1. Active otorrhea or otitis media
2. Otorrhea or otitis media within 4 weeks prior to the operation
3. History of cholesteatoma
4. Perforations on the edge of the tympanic membrane
5. 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
6. Subject is taking systemic/oral corticosteroids
7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Contacts and Locations

Study Contact

Robert Stroup

CONTACT

901-386-0990

robert.stroup@gracemedical.com

Study Locations (Sites)

Michigan Ear Institute

Farmington Hills, Michigan, 48334

United States

Methodist Le Bonheur

Memphis, Tennessee, 38103

United States

Collaborators and Investigators

Sponsor: Grace Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05

Study Completion Date2026-04-20

Study Record Updates

Study Start Date2024-01-05

Study Completion Date2026-04-20

Terms related to this study

Additional Relevant MeSH Terms

Tympanic Membrane Perforation