Tympanoseal (Tympanic Membrane Device) Clinical Study

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.

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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases Wounds and Injuries

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

UT Southwestern Medical Center

Plano, Texas, 75024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tympanoseal

Device

All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.

Primary outcomes

Number of Serious Adverse Events

Time frame: 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:
- Death
- A life-threatening adverse experience
- An inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant disability/incapacity
- A congenital anomaly/birth defect
- Required Intervention to Prevent Permanent Impairment or Damage

Secondary outcomes

Number of Participants With Treatment-related Adverse Events

Time frame: 16 weeks

Determine if any adverse events occur during presence of material on tympanic membrane.

Sponsors and collaborators

Lead sponsor

Grace Medical, Inc.

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Sep 29, 2016
Registry last updated: Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed