Tympanoseal (Tympanic Membrane Device) Clinical Study

Completed

• Conditions: Tympanic Membrane Perforation

• Registration Number: NCT02918942
• Lead Sponsor: Grace Medical, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Study Start: 2016-10-04
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Results First Submitted: 2024-03-19
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Results First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Male or female patients over 2 years of age at enrollment
• Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
• 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

Exclusion Criteria

• Active otorrhea or otitis media
• 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 corticosteroids
• Subject requires continued use of any type of topical otic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events	16 weeks	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 healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. Any serious adverse events (SAE) will be noted.; An SAE is defined as any adverse event occurring that results in any of the following outcomes: 1. Death; 2. A life-threatening adverse experience; 3. An inpatient hospitalization or prolongation of existing hospitalization; 4. A persistent or significant disability/incapacity; 5. A congenital anomaly/birth defect; 6. Required Intervention to Prevent Permanent Impairment or Damage

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events	16 weeks	Determine if any adverse events occur during presence of material on tympanic membrane.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Plano, Texas, United States