Tympanoseal (Tympanic Membrane Device) Clinical Study

September 25, 2024 updated by: Grace Medical, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Plano, Texas, United States, 75024
        • UT Southwestern Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tympanoseal
All subjects will receive the Tympanoseal device.
Device: Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimated)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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